FDA.reportPublic FDA data

BGEcare Non-sterile Gauze Sponge

Primary DI
06972403300541
Brand
BGEcare Non-sterile Gauze Sponge
Company
Xuchang Zhende Surgical Dressing Co., Ltd.
Model
GS0104041220010NS
Device description
BGEcare Non-sterile Gauze Sponge 4''X4'', 12-Ply, 200 pieces/pack,10 packs/carton box
Published
2021-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
06972403300541PackageGS110In Commercial Distribution
06972403300534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972403300541069724033005416972403300541
06972403300534069724033005346972403300534

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, non-sterileA non-medicated, non-sterile 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 cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528104096
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
06972403301043BGEcare Sterile Gauze SpongeGS01040408025012S-12021-03-11
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
06972403300565BGEcare Non-sterile Gauze SpongeGS0104041220020NS2021-03-11

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