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®, SET, RECTANGLE. Includes: 126-SCB-00-001 - SCANCOAT®, RECTANGLE, 6" x 4" x .50" (00810050243889), 126-SCB-00-002 - SCANCOAT®, RECTANGLE, 6" x 4" x 1" (00810050243896), 126-SCB-00-003 - SCANCOAT®, RECTANGLE, 6" x 4" x 1.50" (00810050243902), 126-SCB-00-004 - SCANCOAT®, RECTANGLE, 6" x 4" x 2" (00810050243919) FDA UDI
Model / Reference: 126-SCB FDA UDI
Description: SCANCOAT®, SET, RECTANGLE. Includes: 126-SCB-00-001 - SCANCOAT®, RECTANGLE, 6" x 4" x .50" (00810050243889), 126-SCB-00-002 - SCANCOAT®, RECTANGLE, 6" x 4" x 1" (00810050243896), 126-SCB-00-003 - SCANCOAT®, RECTANGLE, 6" x 4" x 1.50" (00810050243902), 126-SCB-00-004 - SCANCOAT®, RECTANGLE, 6" x 4" x 2" (00810050243919) FDA UDI

Identifiers

Primary DI / UDI-DI: 00810050243926 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

Similar devices

Also classified as Multifunction body cushion.

Birkova — STERIS CORPORATION · Class I
Lounge Doctor — Legs 4 Life, LLC · Class I
PROCARE — DJO, LLC · Class I
Birkova — STERIS CORPORATION · Class I
Birkova — STERIS CORPORATION · Class I
PROCARE — DJO, LLC · Class I
Birkova — STERIS CORPORATION · Class I
ManaMed Inc — MANAMED LLC · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Domico Med-Device, Llc

Sources (1)

FDA UDI be4415c1-cf5f-4ea4-adab-6b9f5da4ebf0 33 fields · synced May 31, 2026