FDA.reportPublic FDA data

GAUZE SWABS

Primary DI
06979109839986
Brand
GAUZE SWABS
Company
Xuchang Zhende Surgical Dressing Co., Ltd.
Model
P162C126001
Device description
Gauze swabs 32s/19*9 10*10cm-8P no edge folding,200 pieces per white paper strip, 40 strips per cubic bag/outer box
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06979109839986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979109839986069791098399866979109839986

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528104096
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06972403300541BGEcare Non-sterile Gauze SpongeGS0104041220010NS2021-03-11
06972403300565BGEcare Non-sterile Gauze SpongeGS0104041220020NS2021-03-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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