Gd

FDA UDI

Class I (US FDA UDI)

by Jiangsu Guangda Medical Material Group Co., Ltd.

Identity

Trade Name: GD FDA UDI
Generic Name: Radiopaque woven surgical sponge FDA UDI
Device Name: Lap Sponges, 12x12, 1400pc/case Bulk Non-sterile FDA UDI
Model / Reference: 211212PWNB FDA UDI
Description: Lap Sponges, 12x12, 1400pc/case Bulk Non-sterile FDA UDI

Identifiers

Catalog Number: 211212PWNB FDA UDI
Primary DI / UDI-DI: 20850699008627 FDA UDI
FDA Product Code: GDY FDA UDI
GMDN Term: Radiopaque woven surgical sponge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Radiopaque woven surgical sponge

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Jiangsu Guangda Medical Material Group Co., Ltd.

Sources (1)

FDA UDI ff00ee20-b3b5-45d6-b3ba-6cccf1cdf11c 36 fields · synced May 30, 2026