Identity
- Trade Name
- DeRoyal FDA UDI
- Generic Name
- Leg/knee cushion FDA UDI
- Device Name
- Surgical Leg Positioner FDA UDI
- Model / Reference
- M5131 FDA UDI
- Description
- Surgical Leg Positioner FDA UDI
Identifiers
- Catalog Number
- M5131 FDA UDI
- Primary DI / UDI-DI
- 00749756112598 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Leg/knee cushion 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: Leg/knee cushion
DeRoyal by Deroyal Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Leg/knee cushion.
- Birkova — STERIS CORPORATION · Class I
- Birkova — STERIS CORPORATION · Class I
- Birkova — STERIS CORPORATION · Class I
- KNEE SEPARATOR — Walgreen Health Solutions, LLC · Class I
- Birkova — STERIS CORPORATION · Class I
- Birkova — STERIS CORPORATION · Class I
- BoneFoam — Bone Foam, Inc. · Class I
- Birkova — STERIS CORPORATION · 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 6b42c789-949e-444f-b8fa-f4b1928686c9 35 fields · synced Jun 8, 2026