R3 71339166

GUDID 00885556021620

R3 CONSTRAINED ACET LINER 66-70MM

Smith & Nephew, Inc.

Constrained polyethylene acetabular liner

• Primary Device ID: 00885556021620
• NIH Device Record Key: 889df03b-4148-416c-b73b-9e7e338f9eea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R3
• Version Model Number: 71339166
• Catalog Number: 71339166
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556021620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083566

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [R3]

• 00885556741313: NARROW BENT HOHMAN RETRACTOR
• 00885556741306: DA COBRA RETRACTOR
• 00885556740705: CUP ALIGNMENT HANDLE
• 00885556740699: CUP IMPACTOR ADAPTER
• 00885556739280: R3 SCREW-IN TRIAL LINER 0¿8/60
• 00885556738597: SWIVEL CUP INSERTER
• 00885556736302: ALIGNMENT GUIDE
• 00885556736296: R3 CUP IMPACTOR
• 00885556736289: R3 SCREW-IN TRIAL LINER 0 DEGREE 40/56
• 00885556736272: R3 SCREW-IN TRIAL LINER 20 DEGREE 36/52
• 00885556732908: SUPERPATH RETRACTOR
• 00885556732892: U-RETRACTOR
• 00885556732670: R3 SCREW-IN TRIAL LINER 20¿6/56
• 00885556732663: R3 SCREW-IN TRIAL LINER 20¿6/54
• 00885556732656: R3 SCREW-IN TRIAL LINER 20¿6/52
• 00885556732649: R3 SCREW-IN TRIAL LINER 20¿2/50
• 00885556732632: R3 SCREW-IN TRIAL LINER 20¿2/48
• 00885556732625: R3 SCREW-IN TRIAL LINER 0¿6/56
• 00885556732618: R3 SCREW-IN TRIAL LINER 0¿6/54
• 00885556732601: R3 SCREW-IN TRIAL LINER 0¿6/52
• 00885556732595: R3 SCREW-IN TRIAL LINER 0¿2/50
• 00885556732588: R3 SCREW-IN TRIAL LINER 0¿2/48
• 00885556732564: R3 CUP IMPACTOR
• 00885556732557: MODIFIED R3 INSERTER
• 00885556732540: R3 ANTI-ROTATION TIP W/FLAT SZ66/68MM
• 00885556732533: R3 ANTI-ROTATION TIP W/FLAT SZ64MM
• 00885556732526: R3 ANTI-ROTATION TIP W/FLAT SZ62MM
• 00885556732519: R3 ANTI-ROTATION TIP W/FLAT SZ60MM
• 00885556732502: R3 ANTI-ROTATION TIP W/FLAT SZ58MM
• 00885556732496: R3 ANTI-ROTATION TIP W/FLAT SZ56MM
• 00885556732472: R3 ANTI-ROTATION TIP W/FLAT SZ54MM
• 00885556732465: R3 ANTI-ROTATION TIP W/FLAT SZ52MM
• 00885556732458: R3 ANTI-ROTATION TIP W/FLAT SZ50MM
• 00885556732441: R3 ANTI-ROTATION TIP W/FLAT SZ48MM
• 00885556732434: R3 ANTI-ROTATION TIP W/FLAT SZ46MM
• 00885556732144: CANNULA
• 00885556732137: CUP IMPACTOR TIP
• 00885556732120: LINER IMPACTOR - 40MM
• 00885556732113: LINER IMPACTOR - 36MM
• 00885556732106: LINER IMPACTOR - 32MM
• 00885556732090: LINER IMPACTOR - 28MM
• 00885556732083: REAMER CONNECTOR
• 00885556732076: INSERTER TOOL
• 00885556732069: LINER IMPACTOR FORCEPS
• 00885556732052: IMPACTOR HANDLE
• 00885556732045: REAMER HANDLE
• 00885556732038: TROCAR
• 00885556732021: HANDS FREE RETRACTOR - RIGHT
• 00885556732014: HANDS FREE RETRACTOR - LEFT
• 00885556732007: LARGE ANTERIOR RETRACTOR