Identity
- Trade Name
- Birkova FDA UDI
- Generic Name
- Freestanding headrest, single-use FDA UDI
- Device Name
- Head Positioner Donut, xLarge 10 inch outer diameter x 6 inch inner diameter x 2 inch height FDA UDI
- Model / Reference
- Table Pads FDA UDI
- Description
- Head Positioner Donut, xLarge 10 inch outer diameter x 6 inch inner diameter x 2 inch height FDA UDI
Identifiers
- Catalog Number
- PP5225 FDA UDI
- Primary DI / UDI-DI
- 00724995213060 FDA UDI
- FDA Product Code
- LWG FDA UDI
- GMDN Term
- Freestanding headrest, single-use 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
Yes
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
Yes
FDA UDI
Category: Freestanding headrest, single-use
Birkova by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding headrest, single-use.
- PRON HEADREST — BIRD & CRONIN, LLC · Class I
- PILLOW, GENTLETOUCH 6 INCH RT — Mizuho Orthopedic Systems, Inc. · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- HEADREST, 9" DONUT — Mizuho Orthopedic Systems, Inc. · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · 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
- Steris Corporation
Sources (1)
- FDA UDI 756b3909-1d86-47a3-852c-1545bdd3483c 35 fields · synced Jun 6, 2026