Identity
- Trade Name
- Soule Medical FDA UDI
- Generic Name
- Freestanding headrest, single-use FDA UDI
- Device Name
- 7" Height Prone Headrest. With Comfort Foam and Right Side Intubation Slot FDA UDI
- Model / Reference
- CF1007 FDA UDI
- Description
- 7" Height Prone Headrest. With Comfort Foam and Right Side Intubation Slot FDA UDI
Identifiers
- Catalog Number
- CF1007 FDA UDI
- Primary DI / UDI-DI
- 00810082222340 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Freestanding headrest, single-use
Soule Medical by Soule Co., The — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Freestanding headrest, single-use.
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- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
- DONUT, POSTION, 7" FOAM BLUE — Mizuho Orthopedic Systems, Inc. · Class I
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class I
- SurgyPad — U.S. SURGITECH 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 |
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Manufacturer
- Manufacturer
- Soule Co., The
Sources (1)
- FDA UDI 406a4f8f-ea63-4ba6-9058-7f457fc5f6ae 34 fields · synced Jun 1, 2026