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Patient Gown

FDA UDI

Class I (US FDA UDI)

by Standard Textile Co., Inc.

Identity

Trade Name
PATIENT GOWN FDA UDI
Generic Name
Patient gown, reusable FDA UDI
Device Name
PATIENT GOWN 3 ARM HOLE HP RNBW OSFA WRAP AROUND W/NO TT/MS SR 9783 FDA UDI
Model / Reference
7470A998 FDA UDI
Description
PATIENT GOWN 3 ARM HOLE HP RNBW OSFA WRAP AROUND W/NO TT/MS SR 9783 FDA UDI

Identifiers

Catalog Number
7470A998 FDA UDI
Primary DI / UDI-DI
00634916016802 FDA UDI
FDA Product Code
FME FDA UDI
GMDN Term
Patient gown, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6265 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: Patient gown, reusable

Patient Gown by Standard Textile Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient gown, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI fedf295a-2d2c-4412-b171-95c6e2952ae8 35 fields · synced Jun 1, 2026