FDA.reportPublic FDA data

BGEcare Sterile Gauze Sponge

Primary DI
06972403301043
Brand
BGEcare Sterile Gauze Sponge
Company
Xuchang Zhende Surgical Dressing Co., Ltd.
Model
GS01040408025012S-1
Device description
BGEcare Sterile Gauze Sponge 4''X4'', 8-Ply, 2 pieces/pack, 50 packs/box, 12 boxes/carton box
Published
2021-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972403301050PackageGS150In Commercial Distribution
06972403301067PackageGS112In Commercial Distribution
06972403301043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403301050069724033010506972403301050
06972403301067069724033010676972403301067
06972403301043069724033010436972403301043

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, non-antimicrobialA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
528104096
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979109839986GAUZE SWABSP162C1260012026-03-16
06972403300480BGEcare Sterile Gauze SpongeGS01040408025012S2021-03-11
06972403300985BGEcare Sterile Gauze SpongeGS01020208025030S2021-03-11
06972403301012BGEcare Sterile Gauze SpongeGS01030308025024S2021-03-11
06972403301074BGEcare Sterile Gauze SpongeGS01020212025045S2021-03-11
06972403301104BGEcare Sterile Gauze SpongeGS01030312024030S2021-03-11
06972403301135BGEcare Sterile Gauze SpongeGS01040412022524S2021-03-11
06972403307601Cardinal Health28700-NS12023-06-28
06972403307717CardinalHealth68342023-06-29
06972403307571ZDZ530M22012023-06-28
06972403307564ZDZ530M22012023-06-28
06972403300596BGEcare Sterile Lap SpongeLS041818040540S2021-03-11
06972403300619BGEcare Sterile Lap SpongeLS04181804051004S2021-03-08
06972403300534BGEcare Non-sterile Gauze SpongeGS0104041220010NS2021-03-11
06972403300558BGEcare Non-sterile Gauze SpongeGS0104041220020NS2021-03-11
06972403300909BGEcare Non-sterile Gauze SpongeGS0102020820025NS2021-03-11
06972403300947BGEcare Non-sterile Gauze SpongeGS0103030820020NS2021-03-11
06972403300497BGEcare Sterile Gauze SpongeGS01040408025012S2021-03-11
06972403300541BGEcare Non-sterile Gauze SpongeGS0104041220010NS2021-03-11
06972403300565BGEcare Non-sterile Gauze SpongeGS0104041220020NS2021-03-11

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