Identity
- Trade Name
- DONUT, POSTION, 7" FOAM BLUE FDA UDI
- Generic Name
- Freestanding headrest, single-use FDA UDI
- Model / Reference
- 1922 FDA UDI
Identifiers
- Catalog Number
- 1922 FDA UDI
- Primary DI / UDI-DI
- 00842430105852 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Freestanding headrest, 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Freestanding headrest, single-use
Donut, Postion, 7" Foam Blue by Mizuho Orthopedic Systems, Inc. — 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
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- Soule Medical — SOULE CO., THE · Class I
- Halyard — OWENS & MINOR DISTRIBUTION, 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
- Mizuho Orthopedic Systems, Inc.
Sources (1)
- FDA UDI 172f80fe-8133-4c85-80d8-01b574202fa6 34 fields · synced Jun 9, 2026