BGEcare Sterile Non-woven Sponge

FDA UDI

Class I (US FDA UDI)

by Henan Zhende Medical Products Co., Ltd.

Identity

Trade Name: BGEcare Sterile Non-woven Sponge FDA UDI
Generic Name: Non-woven gauze pad FDA UDI
Device Name: BGEcare Sterile Non-woven Sponge 2"X2", 4-Ply, 2 pieces/pack, 50 packs/box, 30boxes/carton box FDA UDI
Model / Reference: NS06020204025030S FDA UDI
Description: BGEcare Sterile Non-woven Sponge 2"X2", 4-Ply, 2 pieces/pack, 50 packs/box, 30boxes/carton box FDA UDI

Identifiers

Primary DI / UDI-DI: 06972403420225 FDA UDI
FDA Product Code: FRL FDA UDI
GMDN Term: Non-woven gauze pad FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Non-woven gauze pad

BGEcare Sterile Non-woven Sponge by Henan Zhende Medical Products 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: Henan Zhende Medical Products Co., Ltd.

Sources (1)

FDA UDI b7a0f812-cb66-46c8-8142-4caa28960824 33 fields · synced Jun 1, 2026