BIRMINGHAM HIPTM RESURFACING 901250

GUDID 03596010503459

BHR SLEEVE RING SIZE 50

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 03596010503459
• NIH Device Record Key: 5c85e921-8d28-4708-ad96-181127936804
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIRMINGHAM HIPTM RESURFACING
• Version Model Number: 901250
• Catalog Number: 901250
• Company DUNS: 045483575
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)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	03596010503459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040033

FDA Product Code

• NXT: Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Sterilization

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

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

[03596010503459]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-07
• Device Publish Date: 2015-11-25

On-Brand Devices [BIRMINGHAM HIPTM RESURFACING]

• 00885556075319: BHR TRIAL HEAD KIT
• 03596010503077: MODULAR HEAD 46 MM -8MM
• 03596010503039: MODULAR HEAD 42 MM -8MM
• 03596010533777: BHR INSTRUMENT TRAY 4
• 03596010533760: BIRMINGHAM HIP INSTRUMENT TRAY 3
• 03596010533753: BIRMINGHAM HIP INSTRUMENT TRAY 2
• 03596010533746: BIRMINGHAM HIP INSTRUMENT TRAY 1
• 03596010503541: BHR HEAD CENTRE CHECK JIG SZ 58
• 03596010503527: BHR HEAD CENTRE CHECK JIG SZ 54
• 03596010503510: BHR HEAD CENTRE CHECK JIG SZ 46
• 03596010503503: BHR HEAD CENTRE CHECK JIG SZ 42
• 03596010503497: BHR HEAD CENTRE CHECK JIG SZ 38
• 03596010503480: BHR CHECK JIG MAIN BODY
• 03596010503459: BHR SLEEVE RING SIZE 50
• 03596010503442: BHR SLEEVE RING SZ 46
• 03596010503435: BHR SLEEVE RING SZ 42
• 03596010503428: BHR SLEEVE RING SZ 38