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Scancoat

FDA UDI

Class II (US FDA UDI)

by Domico Med-Device, Llc

Identity

Trade Name
Scancoat FDA UDI
Generic Name
Multifunction body cushion FDA UDI
Device Name
SCANCOAT®, WEDGE, 11" x 7" x 30" FDA UDI
Model / Reference
201-SCB FDA UDI
Description
SCANCOAT®, WEDGE, 11" x 7" x 30" FDA UDI

Identifiers

Primary DI / UDI-DI
00810050244190 FDA UDI
FDA Product Code
KXJ FDA UDI
CCX FDA UDI
GMDN Term
Multifunction body cushion FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1980 FDA UDI
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

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

Dimensions & Sizes

Size
Height — 11 Inch FDA UDI
Width — 7 Inch FDA UDI
Length — 30 Inch FDA UDI

Category: Radiological general body-part positionerMultifunction body cushion

Scancoat by Domico Med-Device, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multifunction body cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Domico Med-Device, Llc

Sources (1)

  • FDA UDI af469f22-f3ac-4d1d-a97a-b98cdc2a8503 34 fields · synced Jun 6, 2026