Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Spinal surgery positioning board FDA UDI
- Device Name
- Custom 4-Post Spine Positioning Kit: includes (2) Chest Posts, (2) Hip Posts, Velcro Base w Handles, Per Each FDA UDI
- Model / Reference
- TA-1592-714 FDA UDI
- Description
- Custom 4-Post Spine Positioning Kit: includes (2) Chest Posts, (2) Hip Posts, Velcro Base w Handles, Per Each FDA UDI
Identifiers
- Catalog Number
- TA-1592-714 FDA UDI
- Primary DI / UDI-DI
- 10810087355903 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Spinal surgery positioning board FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 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
Yes
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
Category: Spinal surgery positioning board
Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal surgery positioning board.
- Lateral Patient Positioning System — ALPHATEC SPINE, INC. · Class I
- WILSON PLUS RADIOLUCENT FRAME REFURB — Mizuho Orthopedic Systems, Inc. · Class I
- AIS Patient Positioner — ALPHATEC SPINE, INC. · Class I
- AIS Patient Positioner — ALPHATEC SPINE, INC. · Class I
- Lateral Patient Positioning System — ALPHATEC SPINE, INC. · Class I
- Lateral Patient Positioning System — ALPHATEC SPINE, INC. · Class I
- Support plate — Maquet, Inc. · Class I
- Kneeling frame — Maquet, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coulmed Products Group Llc
Sources (1)
- FDA UDI 0c7c1e7e-81f6-43fd-b8b2-3a46e473362a 34 fields · synced May 29, 2026