FDA.reportPublic FDA data

HCS

Primary DI
00810132043956
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
92212NS
Device description
Gauze Sponge 2x2, 4ply Non-Sterile
Published
2025-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EYFProtector, Wound, Plastic
GDYGauze/Sponge, Internal, X-Ray Detectable
NABGauze / Sponge,Nonresorbable For External Use
OVRKit, First Aid, Talking

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYFProtector, Wound, PlasticGeneral, Plastic Surgery1
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1
OVRKit, First Aid, TalkingGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810132043953PackageGS140In Commercial Distribution
00810132043956PrimaryGS10
20810132043950Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204395310810132043953
00810132043956008101320439568101320439560810132043956
2081013204395020810132043950

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
200
Premarket exempt
true
Manufacturing date on label
true

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
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06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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