Identity
- Trade Name
- COMPREHENSIVE REVERSE SHOULDER FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Model / Reference
- 010001826 FDA UDI
Identifiers
- Catalog Number
- 010001826 FDA UDI
- Primary DI / UDI-DI
- 00880304538795 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDIPAO FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant-instrument extension adaptor, reusable
Comprehensive Reverse Shoulder by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
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- ACS® — implantcast GmbH · Class I
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Cleared under the same submission
K080642 also covers:
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc.
K193373 also covers:
- COMPREHENSIVE — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTATION — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 101b0755-bc47-4d36-b129-12be5d9f9b28 35 fields · synced Jun 6, 2026