Identity
- Trade Name
- COMPREHENSIVE® SHOULDER INSTRUMENTS FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Model / Reference
- 41-406808 FDA UDI
Identifiers
- Catalog Number
- 41-406808 FDA UDI
- Primary DI / UDI-DI
- 00880304450943 FDA UDI
- FDA Product Code
- KWS FDA UDIMBF FDA UDIHSD FDA UDIKWT FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI888.3690 FDA UDI888.3650 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medullary canal orthopaedic reamer, rigid
Comprehensive® Shoulder Instruments by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medullary canal orthopaedic reamer, rigid.
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Cleared under the same submission
K140390 also covers:
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE® SHOULDER INSTRUMENTS — Biomet Orthopedics, Inc.
K193038 also covers:
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE(R) SHOULDER SYSTEM — 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 838142c4-984d-4973-9f6a-3a6656276429 36 fields · synced May 30, 2026