Identity
- Trade Name
- Comprehensive® Instruments FDA UDICOMPREHENSIVE INSTRUMENTS FDA UDI
- Generic Name
- Glenoid orthopaedic reamer FDA UDIBone-resection orthopaedic reamer, reusable FDA UDI
- Model / Reference
- 110003472 FDA UDI
Identifiers
- Catalog Number
- 110003472 FDA UDI
- Primary DI / UDI-DI
- 00887868462573 FDA UDI00880304539433 FDA UDI
- FDA Product Code
- HSD FDA UDIMBF FDA UDIKWT FDA UDIKWS FDA UDI
- GMDN Term
- Glenoid orthopaedic reamer FDA UDIBone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3670 FDA UDI888.3650 FDA UDI888.3660 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 UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Glenoid orthopaedic reamer
Comprehensive® Instruments by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glenoid orthopaedic reamer.
- Alliance® — Zimmer, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- LINK Embrace Shoulder System Line Extension — WALDEMAR LINK GmbH & Co. KG · Class I
- Alliance — Zimmer, Inc. · Class II
- PRIMA TT Glenoid — Limacorporate · Class II
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
Cleared under the same submission
K060694 also covers:
- Augmented BP Rmr Gd Inserter — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE INSTRUMENTS — Biomet Orthopedics, Inc.
- COMPREHENSIVE 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 (2)
- FDA UDI 1c544a3d-0d36-4d7c-87ff-039a57f9263b 36 fields · synced Jun 8, 2026
- FDA UDI 69cad9b8-6631-4060-b650-919a0048f77b 36 fields · synced May 27, 2026