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EU / UK REACH Article 33 Communicationa,b
Johnson & Johnson MedTech Companies take compliance with EU and UK REACH very seriously. We regularly assess whether our products contain Substances of Very High Concern (SVHC) included in the Candidate Lists of EU and UK REACH in a concentration above 0.1 % weight by weight (w/w), which must be disclosed to our customers.
Based on the current version of the Candidate Lists of EU and UK REACH, the following SVHCs are present in Johnson & Johnson MedTech Companies products above the disclosure threshold:
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BIS (2-ETHYLHEXYL) PHTHALATE (DEHP) - CAS # 117-81-7 |
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Sterile View® Knee High Boots1 |
TSS Retractor Light Strip |
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ORACLE Retractor Light Clip - Sterile |
ORACLE Disposables – Disposable Light – Sterile for Lateral Retractor 2 |
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Double Air Hose, length 3m, for System Synthes |
Heated tube set for insufflation |
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Double Air Hos, length 3 m, for System BOC/Schrader |
Double Spiral Air Hose, up to 2 m, for System Synthes |
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Double Air Hose, length 5m, for System Synthes |
Double Air Hose, length 3 m, for System Dräger |
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Double Air Hose, length 5 m, for System BOC/Schrader |
Double Air Hose, length 5 m, for System Dräger |
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Exhaust Air Diffusor |
Double Spiral Air Hose, up to 2 m, for System Dräger |
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Compact Air Drive II |
Adapter for Dräger/Synthes Coupling |
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Adapter for Maintenance Unit, for Nos. 05.001.055 and 05.001.063 |
Adapter for Maintenance Unit No. 05.001.099, for Air Pen Drive |
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Adapter for Schrader/Synthes Coupling |
Adapter for APD Handpiece, for Maintenance Spray No. 05.001.098 |
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Adapter for EPD/APD Attachments, for Maintenance Spray No. 05.001.098 |
Adapter for EPD Handpiece, for Maintenance Spray No. 05.001.098 |
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LCS® Complete knee system |
Sigma® RP knee system |
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ENSEAL® Round Tip Tissue Sealer |
ENSEAL® Trio Tissue Sealer |
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ETHICON Generator Accessories |
ETHICON GEN11 Generator |
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GYNECARE VERSASCOPE Hysteroscopy System Sheath |
J-VAC® CLOSED WOUND DRAINAGE SYSTEM |
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Codman Connecting Cable (CCB) |
Enpower Connecting Cable (ECB) |
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OCTAMETHYLCYCLOTETRASILOXANE (D4) - CAS # 556-67-2 DECAMETHYLCYCLOPENTASILOXANE (D5) - CAS # 541-02-6 DODECAMETHYLCYCLOHEXASILOXANE (D6) - CAS # 540-97-6 |
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USB Keyboard French |
USB Keyboard Italian |
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USB Keyboard Spanish |
USB Keyboard Swedish, Danish, Finish, Norwegian |
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USB Keyboard Portuguese |
USB Keyboard German |
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LEAD - CAS # 7439-92-1 |
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Camera Head with C-mount, Autoclavable |
Camera Control System with Light Source (ROW) |
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FMS Connect Universal Shaver Interface Cable (FMS VUE System) |
FMS Connect Universal Shaver Interface Cable (Duo/ Solo System) 1 |
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Remote Control (FMS VUE System) |
FMS VUE II Fluid Management & Tissue Debridement System |
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Electric Systems Foot Control |
eMax2 Plus Console |
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Electric Systems Foot Control with Direction |
eMax2 Plus Single Port Console with Irrigation |
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Electric Systems Foot Control with Direction and Irrigation |
eMax2 Plus Single Port Console without Irrigation |
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eG1 System Console with Irrigation |
eG1 System Console without Irrigation |
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Power Cord, two-pole (EU) |
Compact Air Drive II |
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Power Cord, two-pole (Great Britain, Ireland, Hong Kong,..) |
Compact Water Bath |
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Power Cord, three-pole, Europe |
Hand Piece for Piezoelectric System |
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Power Cord, three-pole, Great Britain |
Universal Battery Charger II |
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Power Cord, three-pole, Denmark |
Lid for No. 05.001.201 (modular), for Trauma Recon System |
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Power Cord, three-pole, North America |
Battery Handpiece, Recon Sagittal Saw, with T-Handle, for Trauma Recon System |
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Power Cord, three-pole, Italy |
Lid for No. 05.001.240 (Recon Saw), for Trauma Recon System |
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Torque Limiter, 0.4 Nm, with AO/ASIF Quick Coupling |
Torque Limiter, 1.5 Nm, for Compact™ Air Drive and Power Drive |
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Torque Limiter, 1.5 Nm, for AO/ASIF Quick Coupling |
Torque Limiter, 4 Nm, for AO/ASIF Quick Coupling for Reamers |
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Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling |
Torque Limiter, 0.8 Nm, with AO/ASIF Quick Coupling |
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SPECTRA Detachment Control Box (DCB2) |
Device Positioning Unit (DPU) 3 Subassembly |
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2nd Generation Detachment Control Box (DCB05) |
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EDGME - CAS # 110-71-4 |
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ECHELON FLEX™ Powered Vascular Stapler |
ECHELON CIRCULAR™ Powered Stapler |
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PZT - CAS # 12626-81-2 |
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HARMONIC® HD 1000i Shears |
HARMONIC® Hand Pieces |
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UV-328 - CAS # 25973-55-1 |
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ECHELON FLEX™ GST System |
ETHICON™ Linear Cutters |
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HARMONIC SYNERGY® Blades |
ETHICON™ Circular Staplers |
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ENSEAL® G2 Super Jaw Tissue Sealer |
ECHELON FLEX™ Articulating Endoscopic Linear Cutter |
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ECHELON FLEX™ ENDOPATH® Staplers |
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Other Third-Party Articles Made Available |
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BIS (2-ETHYLHEXYL) PHTHALATE (DEHP) - CAS # 117-81-7 |
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DePuy Synthes Summit SmartMix CTS Vacuum Mixing Bowl |
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LEAD - CAS # 7439-92-1 |
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EPIPHAN AV.IO HD USB VIDEO GRABBER (Component of DePuy Synthes Velys™ Hip Navigation) |
STARTECH.COM DP to DVI Single Link Converter (Component of DePuy Synthes Velys™ Hip Navigation) |
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Sony® UP-DR80MD Printer |
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a EU REACH is defined as Regulation (EC) No. 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals.
b UK REACH is defined as The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019, as amended by the relevant UK Statutory Instruments.
1 Product discontinued or obsolete in 2020.
2 Product produced after December 3rd, 2019 does not contain DEHP