Identity
- Trade Name
- ORTHOMED FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- F-S KERR.RONG.7" 6MM FWRD.THIN FOOT FDA UDI
- Model / Reference
- OM 48-0042 FDA UDI
- Description
- F-S KERR.RONG.7" 6MM FWRD.THIN FOOT FDA UDI
Identifiers
- Primary DI / UDI-DI
- B8034800420 FDA UDI
- FDA Product Code
- LRY FDA UDI
- GMDN Term
- Spinal rongeur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
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: Spinal rongeur
Orthomed by Ortho-Med, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal rongeur.
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- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- V. Mueller — STERIS CORPORATION · Class II
- Boss Instruments — Boss Instruments, Ltd. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ortho-Med, Inc.
Sources (1)
- FDA UDI 6de07783-a037-4a03-9683-929138fe4058 33 fields · synced May 31, 2026