Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Freestanding patient positioner, single-use FDA UDI
- Device Name
- Anesthesia Prone Head Rest (Adult) Complete Set, (1) 10-5/8" x 9" x 3-1/2" Gel Pad + 3 Foam Base Sizes (1", 2", & 3") included, per set FDA UDI
- Model / Reference
- GP216 FDA UDI
- Description
- Anesthesia Prone Head Rest (Adult) Complete Set, (1) 10-5/8" x 9" x 3-1/2" Gel Pad + 3 Foam Base Sizes (1", 2", & 3") included, per set FDA UDI
Identifiers
- Catalog Number
- GP216 FDA UDI
- Primary DI / UDI-DI
- 10810087351301 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 patient positioner, single-use
Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Coulmed Products Group Llc
Sources (1)
- FDA UDI 5ab506de-2ea8-4341-ab37-bae15ae80850 34 fields · synced May 30, 2026