OXINIUM 71342612

GUDID 03596010514233

OXINIUM FEMORAL HEAD 12/14 TAPER 26 MM +12

Smith & Nephew, Inc.

Metallic femoral head prosthesis

• Primary Device ID: 03596010514233
• NIH Device Record Key: 413457d6-e7cb-4f5a-9c6e-58a4698d9f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXINIUM
• Version Model Number: 71342612
• Catalog Number: 71342612
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010514233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021673

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-08-30

On-Brand Devices [OXINIUM]

• 00885556689394: OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +16
• 00885556533895: OXINIUM 10/12 TAPER FEMORAL HEAD 36MM +5
• 00885556533888: OXINIUM 10/12 TAPER FEMORAL HEAD 36MM +0
• 00885556533802: OXINIUM 10/12 TAPER FEMORAL HEAD 36MM -5
• 00885556112540: OXINIUM FEMORAL HEAD 10/12 22MM -3 EXT
• 00885556112533: OXINIUM FEMORAL HEAD 10/12 22MM +0 EXT
• 00885556112526: OXINIUM FEMORAL HEAD 10/12 22MM +3 EXT
• 00885556112519: OXINIUM FEMORAL HEAD 10/12 26MM -5 EXT
• 00885556112502: OXINIUM FEMORAL HEAD 10/12 26MM +0 EXT
• 00885556112496: OXINIUM FEMORAL HEAD 10/12 26MM +5 EXT
• 00885556112489: OXINIUM FEMORAL HEAD 10/12 28MM -5 EXT
• 00885556112472: OXINIUM FEMORAL HEAD 10/12 28MM +0 EXT
• 00885556112465: OXINIUM FEMORAL HEAD 10/12 28MM +5 EXT
• 00885556112458: OXINIUM FEMORAL HEAD 10/12 32MM -5 EXT
• 00885556112441: OXINIUM FEMORAL HEAD 10/12 32MM +0 EXT
• 00885556112434: OXINIUM FEMORAL HEAD 10/12 32MM +5 EXT
• 00885556112410: 40MM OXINIUM MODULAR FEMORAL HEAD
• 03596010652003: 44MM OXINIUM MODULAR FEMORAL HEAD
• 03596010537492: OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +12
• 03596010534774: OXINIUM UNIPOLAR HEAD 55MM OD
• 03596010534767: OXINIUM UNIPOLAR HEAD 54MM OD
• 03596010534750: OXINIUM UNIPOLAR HEAD 53MM OD
• 03596010534743: OXINIUM UNIPOLAR HEAD 52MM OD
• 03596010534736: OXINIUM UNIPOLAR HEAD 51MM OD
• 03596010534729: OXINIUM UNIPOLAR HEAD 50MM OD
• 03596010534712: OXINIUM UNIPOLAR HEAD 49MM OD
• 03596010534705: OXINIUM UNIPOLAR HEAD 48MM OD
• 03596010534699: OXINIUM UNIPOLAR HEAD 47MM OD
• 03596010534682: OXINIUM UNIPOLAR HEAD 46MM OD
• 03596010534675: OXINIUM UNIPOLAR HEAD 45MM OD
• 03596010534668: OXINIUM UNIPOLAR HEAD 44MM OD
• 03596010534651: OXINIUM UNIPOLAR HEAD 43MM OD
• 03596010534644: OXINIUM UNIPOLAR HEAD 42MM OD
• 03596010534637: OXINIUM UNIPOLAR HEAD 41MM OD
• 03596010534620: OXINIUM UNIPOLAR HEAD 40MM OD
• 03596010525185: OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +16
• 03596010520449: OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12
• 03596010516275: OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12
• 03596010514233: OXINIUM FEMORAL HEAD 12/14 TAPER 26 MM +12
• 03596010502285: OXINIUM FEM HEAD 14/16 TPR 36MM +8 NECK
• 03596010502278: OXINIUM FEM HEAD 14/16 TPR 36MM +4 NECK
• 03596010502261: OXINIUM FEM HEAD 14/16 TPR 36MM +0 NECK
• 03596010502254: OXINIUM FEM HEAD 14/16 TPR 28MM +8 NECK
• 03596010502247: OXINIUM FEM HEAD 14/16 TPR 28MM +4 NECK
• 03596010502230: OXINIUM FEM HEAD 14/16 TPR 28MM +0 NECK
• 03596010502032: OXINIUM FEM HEAD 14/16 TPR 32MM +8 NECK
• 03596010502025: OXINIUM FEM HEAD 14/16 TPR 32MM +4 NECK
• 03596010502018: OXINIUM FEM HEAD 14/16 TPR 32MM +0 NECK
• 03596010491060: OXINIUM UNI INSTRUMENT TRAY
• 03596010488916: OXINIUM FEMORAL HEAD 12/14 TAPER 26 MM +8