Identity
- Trade Name
- Comprehensive SRS FDA UDI
- Generic Name
- Coated shoulder humeral stem prosthesis FDA UDI
- Model / Reference
- 211298 FDA UDI
Identifiers
- Catalog Number
- 211298 FDA UDI
- Primary DI / UDI-DI
- 00880304714748 FDA UDI
- FDA Product Code
- KWS FDA UDIMBF FDA UDIKWT FDA UDIJDC FDA UDIPHX FDA UDI
- GMDN Term
- Coated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI888.3650 FDA UDI888.3150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Coated shoulder humeral stem prosthesis
Comprehensive SRS by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coated shoulder humeral stem prosthesis.
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Cleared under the same submission
K111746 also covers:
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS HEX DRIVER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
- COMPREHENSIVE SRS INSTRUMENT — Biomet Orthopedics, Inc.
K173411 also covers:
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- Comprehensive SRS — Biomet Orthopedics, Inc.
- Comprehensive SRS — Biomet Orthopedics, Inc.
- Comprehensive SRS — Biomet Orthopedics, Inc.
- Comprehensive SRS — Biomet Orthopedics, Inc.
- Comprehensive SRS — Biomet Orthopedics, Inc.
- Comprehensive SRS — Biomet Orthopedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI fcf227e1-2876-4286-a067-b8d9ffbc0450 36 fields · synced May 30, 2026