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®, KIT, SMALL, "A". Includes: 112-SCB - SCANCOAT®, DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241885), 114-SCB - SCANCOAT®, RECTANGLE, 2” x 7.5” x 9.5” (00810050241922), 116-SCB - SCANCOAT®, WEDGE, 3” x 4” x 7” (10810050242810), 117-SCB - SCANCOAT®, WEDGE, 2.5” x 7” x 10” (10810050242797), 118-SCB - SCANCOAT®, WEDGE, 7” x 7” x 7” (00810050242073) FDA UDI
Model / Reference: 4-SCB FDA UDI
Description: SCANCOAT®, KIT, SMALL, "A". Includes: 112-SCB - SCANCOAT®, DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241885), 114-SCB - SCANCOAT®, RECTANGLE, 2” x 7.5” x 9.5” (00810050241922), 116-SCB - SCANCOAT®, WEDGE, 3” x 4” x 7” (10810050242810), 117-SCB - SCANCOAT®, WEDGE, 2.5” x 7” x 10” (10810050242797), 118-SCB - SCANCOAT®, WEDGE, 7” x 7” x 7” (00810050242073) FDA UDI

Identifiers

Primary DI / UDI-DI: 00810050243360 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological general body-part positioner Multifunction body cushion

Scancoat by Domico Med-Device, Llc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Domico Med-Device, Llc

Sources (1)

FDA UDI 35b33cd3-b63b-4e67-8845-3e0362646548 33 fields · synced Jun 1, 2026