← Back to catalogue

DeRoyal

FDA UDI

Class I (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
Heel protector FDA UDI
Device Name
Decubitus Pads FDA UDI
Model / Reference
M92D3251 FDA UDI
Description
Decubitus Pads FDA UDI

Identifiers

Catalog Number
M92D3251 FDA UDI
Primary DI / UDI-DI
00749756146159 FDA UDI
FDA Product Code
FMP FDA UDI
GMDN Term
Heel protector FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6450 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Heel protector

DeRoyal by Deroyal Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heel protector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Sources (1)

  • FDA UDI 4c218702-6de2-48b2-8876-193225013f31 35 fields · synced Jun 8, 2026