Titan Humeral Resurfacing Arthroplasty HRA-900-44/18-WW

GUDID 00885556837221

HRA COMPONENT SZ. 44/18

Smith & Nephew, Inc.

Resurfacing humeral head prosthesis

• Primary Device ID: 00885556837221
• NIH Device Record Key: e4f77ec5-456b-4ae7-9e4a-82fbc5ef3c0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Humeral Resurfacing Arthroplasty
• Version Model Number: HRA-900-44/18-WW
• Catalog Number: HRA-900-44/18-WW
• 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)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
• 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	00885556837221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062861

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC 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: 2
• Public Version Date: 2023-07-12
• Device Publish Date: 2022-12-22

On-Brand Devices [Titan Humeral Resurfacing Arthroplasty]

• 00885556837450: HUMERAL SIZER/CENTRALIZER SZ. 56-21
• 00885556837443: HUMERAL SIZER/CENTRALIZER SZ. 52-21
• 00885556837436: HUMERAL SIZER/CENTRALIZER SZ. 52-18
• 00885556837429: HUMERAL SIZER/CENTRALIZER SZ. 48-20
• 00885556837412: HUMERAL SIZER/CENTRALIZER SZ. 48-17
• 00885556837405: HUMERAL SIZER/CENTRALIZER SZ. 44-18
• 00885556837399: HUMERAL SIZER/CENTRALIZER SZ. 44-15
• 00885556837382: HUMERAL SIZER/CENTRALIZER SZ. 40-16
• 00885556837283: HRA IMPACTOR
• 00885556837191: HRA CENTER DRILL SZ. 3
• 00885556837184: HRA CENTER DRILL SZ. 2
• 00885556837177: HRA CENTER DRILL SZ. 1
• 00885556837122: HUMORAL BROACH SZ. 3
• 00885556837115: HUMORAL BROACH SZ. 2
• 00885556837108: HUMORAL BROACH SZ. 1
• 00885556837085: HRA ADAPTER SZ. 3
• 00885556837078: HRA ADAPTER SZ. 2
• 00885556837061: HRA ADAPTER SZ. 1
• 00885556831007: KOLBEL RETRACTOR BLADE X-LARGE
• 00885556830994: KOLBEL RETRACTOR BLADE SMALL
• 00885556830987: KOLBEL RETRACTOR BLADE LARGE
• 00885556830949: GLENOID RETRACTOR SMALL
• 00885556830932: GLENOID RETRACTOR LARGE
• 00885556830901: DARRACH RETRACTOR SMALL
• 00885556830895: DARRACH RETRACTOR LARGE
• 00885556837276: HRA COMPONENT SZ. 56/21
• 00885556837269: HRA COMPONENT SZ. 52/21
• 00885556837252: HRA COMPONENT SZ. 52/18
• 00885556837245: HRA COMPONENT SZ. 48/20
• 00885556837238: HRA COMPONENT SZ. 48/17
• 00885556837221: HRA COMPONENT SZ. 44/18
• 00885556837214: HRA COMPONENT SZ. 44/15
• 00885556837207: HRA COMPONENT SZ. 40/16
• 00885556837535: HRA TRIAL SZ. 56/21
• 00885556837528: HRA TRIAL SZ. 52/21
• 00885556837511: HRA TRIAL SZ. 52/18
• 00885556837504: HRA TRIAL SZ. 48/20
• 00885556837498: HRA TRIAL SZ. 48/17
• 00885556837481: HRA TRIAL SZ. 44/18
• 00885556837474: HRA TRIAL SZ. 44/15
• 00885556837467: HRA TRIAL SZ. 40/16
• 00885556837375: HRA SHAPER SZ. 56/21
• 00885556837368: HRA SHAPER SZ. 52/21
• 00885556837351: HRA SHAPER SZ. 52/18
• 00885556837344: HRA SHAPER SZ. 48/20
• 00885556837337: HRA SHAPER SZ. 48/17
• 00885556837320: HRA SHAPER SZ. 44/18
• 00885556837313: HRA SHAPER SZ. 44/15
• 00885556837306: HRA SHAPER SZ. 40/16
• 00885556837160: HRA BOTTOM TRAY