Identity
- Trade Name
- Scancoat FDA UDI
- Generic Name
- Multifunction body cushion FDA UDI
- Device Name
- SCANCOAT®, KIT, SMALL. Includes: 128-SCB - SCANCOAT®, WEDGE, 3" x 10" x 10" (00810050244053), 129-SCB - SCANCOAT®, WEDGE, 4.63 x 10” x 10” (00810050240321), 130-SCB - SCANCOAT®, WEDGE, 10" x 10" x 10" (00810050244060), 140-SCB - SCANCOAT®, WEDGE, 6" x 10" x 10" (00810050243629) FDA UDI
- Model / Reference
- 7-SCB FDA UDI
- Description
- SCANCOAT®, KIT, SMALL. Includes: 128-SCB - SCANCOAT®, WEDGE, 3" x 10" x 10" (00810050244053), 129-SCB - SCANCOAT®, WEDGE, 4.63 x 10” x 10” (00810050240321), 130-SCB - SCANCOAT®, WEDGE, 10" x 10" x 10" (00810050244060), 140-SCB - SCANCOAT®, WEDGE, 6" x 10" x 10" (00810050243629) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810050244077 FDA UDI
- FDA Product Code
- KXJ FDA UDICCX FDA UDI
- GMDN Term
- Multifunction body cushion FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 FDA UDI868.6820 FDA UDI
- Commercial Distribution
- Not 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
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
Scancoat by Domico Med-Device, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Domico Med-Device, Llc
Sources (1)
- FDA UDI 9de3df8f-9e03-4447-a770-fc19395ff4ba 34 fields · synced May 30, 2026