Identity
- Trade Name
- DeRoyal FDA UDI
- Generic Name
- Freestanding patient positioner, single-use FDA UDI
- Device Name
- FOAM LUMBAR ROLL FDA UDI
- Model / Reference
- M10-093-C FDA UDI
- Description
- FOAM LUMBAR ROLL FDA UDI
Identifiers
- Catalog Number
- M10-093-C FDA UDI
- Primary DI / UDI-DI
- 00749756006149 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Freestanding patient positioner, single-use 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Freestanding patient positioner, single-use
DeRoyal by Deroyal Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding patient positioner, single-use.
- Span-America — Span-America Medical Systems, Inc. · Class I
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Soule Medical — SOULE CO., THE · Class I
- 40527 DermaProx Pad 8'' x 11'' x 1/2'' — XODUS MEDICAL, INC. · Class I
- American Hospital Supply — AMERICAN HOSPITAL SUPPLY · Class I
- Prime Medical LLC — Prime Medical LLC · Class I
- HALYARD — OWENS & MINOR DISTRIBUTION, INC. · Class I
- CARDINAL HEALTH — Cardinal Health 200, 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
- Deroyal Industries, Inc.
Sources (1)
- FDA UDI 49926c28-8f1a-415c-bb9c-276e312cc47b 35 fields · synced Jun 8, 2026