← Back to catalogue

DermaTherapy Fitted Sheet

FDA UDI

Class I (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
DermaTherapy Fitted Sheet FDA UDI
Generic Name
Absorbent underpad, non-antimicrobial, reusable FDA UDI
Device Name
DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around, 37x79x10 FDA UDI
Model / Reference
17810100 FDA UDI
Description
DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around, 37x79x10 FDA UDI

Identifiers

Primary DI / UDI-DI
00634916508963 FDA UDI
FDA Product Code
FMW FDA UDI
GMDN Term
Absorbent underpad, non-antimicrobial, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6190 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

Yes

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

No

FDA UDI

Category: Absorbent underpad, non-antimicrobial, reusable

DermaTherapy Fitted Sheet by Standard Textile Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Absorbent underpad, non-antimicrobial, reusable.

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

Manufacturer
Standard Textile Co., Inc.

Sources (1)

  • FDA UDI 0f7c9bb7-f9a8-4cbb-9922-6d88925f323f 34 fields · synced May 30, 2026