Identity
- Trade Name
- COMPREHENSIVE SHOULDER FDA UDI
- Generic Name
- Surgical depth gauge, reusable FDA UDI
- Model / Reference
- 110005302 FDA UDI
Identifiers
- Catalog Number
- 110005302 FDA UDI
- Primary DI / UDI-DI
- 00880304568181 FDA UDI
- 510(k) Number
- K130390 FDA UDI
- FDA Product Code
- PHX FDA UDIPAO FDA UDIKWT FDA UDIMBF FDA UDIKWS FDA UDI
- GMDN Term
- Surgical depth gauge, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 FDA UDI888.3670 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: Surgical depth gauge, reusable
Comprehensive Shoulder by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical depth gauge, reusable.
- Depth Gauge — I.T.S. GmbH · Class I
- FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
- FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Cleared under the same submission
K130390 also covers:
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER — Biomet Orthopedics, Inc.
- COMPREHENSIVE SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- COMPREHENSIVE 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 9c96af05-b446-4eec-8bf6-26cd5b2ae890 36 fields · synced Jun 6, 2026