FDA.reportPublic FDA data

HCS

Primary DI
20810132043981
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
92280-2
Device description
Gauze Sponge, 2x2, 8ply, Sterile
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10810132043984PackageGS130In Commercial Distribution
00810132043987PrimaryGS10
20810132043981Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204398410810132043984
00810132043987008101320439878101320439870810132043987
2081013204398120810132043981

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze padA 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

Regulatory Flags#

DUNS number
080220245
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00810132043789HCS9201-5002026-05-13
00810132043796HCS9201-10002026-05-13
00810132044359HCS3004OHCB23004OHCB22026-03-09
00810132044366HCS Sourcing3004OTCB2XL3004OHCB2XL2026-03-09
00810132044335HCS3011SHU3011SHU2026-03-09
00810132044342HCS3011SHXL3011SHXL2026-03-09
10810132044332HCS3011SHU3011SHU2026-03-09
10810132044349HCS3011SHXL3011SHXL2026-03-09
10810132044356HCS3004OHCB22026-03-09
20810132044360HCS Sourcing3004OTCB2XL2026-03-09
10810132043717HCS6605W2026-01-30
10810132043724HCS6606W2026-01-30
00810132040030HCSHCS40032023-04-21
00810132040047HCSHCS40042023-04-21
00810132040979HCSHCS40012023-04-21
00810132040986HCSHCS40022023-04-21
20810132043714HCS6605W2026-01-30
20810132043721HCS6606W2026-01-30
00810132043000HCS818012026-01-23
00810132043017HCS818022026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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