Identity

Trade Name
GD FDA UDI
Generic Name
Woven gauze roll/sheet FDA UDI
Device Name
Non-sterile Fluftex Gauze Roll, 600Cs FDA UDI
Model / Reference
511-005 FDA UDI
Description
Non-sterile Fluftex Gauze Roll, 600Cs FDA UDI

Identifiers

Catalog Number
511-005 FDA UDI
Primary DI / UDI-DI
10850699008552 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Woven gauze roll/sheet FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Woven gauze roll/sheet

Gd by Jiangsu Guangda Medical Material Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Woven gauze roll/sheet.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 125b15d6-51dd-42e5-80fd-8a094b4821dd 36 fields · synced May 30, 2026