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Pt

FDA UDI

Class I (US FDA UDI)

by Phu Tuong Garment Company Limited

Identity

Trade Name
PT FDA UDI
Generic Name
Visitor hygiene coverall FDA UDI
Device Name
An isolation gown is made of fabric material, either non-woven or woven FDA UDI
Model / Reference
PT02 FDA UDI
Description
An isolation gown is made of fabric material, either non-woven or woven FDA UDI

Identifiers

Primary DI / UDI-DI
18938533047027 FDA UDI
FDA Product Code
OEA FDA UDI
GMDN Term
Visitor hygiene coverall FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Visitor hygiene coverall

Pt by Phu Tuong Garment Company Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Visitor hygiene coverall.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phu Tuong Garment Company Limited

Sources (1)

  • FDA UDI c0a887a4-f120-4550-8115-1fca216b2410 35 fields · synced May 30, 2026