Identity
- Trade Name
- Omnia Medical Coupler-C FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- CERVICAL PLATE BENDER FDA UDI
- Model / Reference
- 15-5C-PBD1 FDA UDI
- Description
- CERVICAL PLATE BENDER FDA UDI
Identifiers
- Catalog Number
- 15-5C-PBD1 FDA UDI
- Primary DI / UDI-DI
- 00843511113636 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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: Manual orthopaedic bender, reusable
Omnia Medical Coupler-C by Omnia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual orthopaedic bender, reusable.
- MESA Small Stature Spinal System — K2M, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Kestrel® — Innovasis, Inc. · Class II
- Surgical Instrument — OSTEONIC CO., Ltd. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Dark Star Deformity — Republic Spine, LLC · Class II
- g Source — GSOURCE, LLC. · Class I
- CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
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
- Omnia Medical
Sources (1)
- FDA UDI bc6e2281-1752-4ba6-b60f-0638ba9bb738 35 fields · synced Jun 6, 2026