Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Device Name
- Dome Wedge Positioner: 9"W x 17-1/2"L x 6-1/2"H. FDA UDI
- Model / Reference
- FP-508-CC FDA UDI
- Description
- Dome Wedge Positioner: 9"W x 17-1/2"L x 6-1/2"H. FDA UDI
Identifiers
- Catalog Number
- FP-508-CC FDA UDI
- Primary DI / UDI-DI
- 10810087350823 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
Category: Freestanding patient positioner, reusable
Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding patient positioner, reusable.
- Inspired by Drive — Drive Devilbiss Healthcare · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- Action® — Action Products, Inc. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- PILLING — TELEFLEX INCORPORATED · Class II
- Rayshield — AADCO MEDICAL, INC. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- WEDGE 20 DEG BLUE VINYL 10X8.5X 3 — AliMed, LLC · 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 3fd1e983-15ac-48fc-ab84-6b87d706dc1c 34 fields · synced Jun 8, 2026