Select Choice

Primary DI
10857425005632
Brand
Select Choice
Company
Hemasource, Inc.
Model
GAU2102
Device description
Select Choice 2" 4 Ply Non Sterile, Non woven Sponge
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10857425005632PackageGS120In Commercial Distribution
00857425005635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085742500563210857425005632
00857425005635008574250056358574250056350857425005635

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009046405
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857425005956TempoICE6650CC2022-12-08
10857425005953TempoICE6650CC2022-12-08
00857425005727TempoSD50230BKA2022-12-08
00891153001811TempoSD4030BK2022-12-08
00891153001927TempoSD5030G2022-12-08
00891153001941TempoSD5030YA2022-12-08
00891153001958TempoSD5030R2022-12-08
00891153001965TempoSD5030O2022-12-08
00891153001989TempoSD5030BEA2022-12-08
10857425005724TempoSD50230BKA2022-12-08
10891153001818TempoSD4030BK2022-12-08
10891153001924TempoSD5030G2022-12-08
10891153001948TempoSD5030YA2022-12-08
10891153001955TempoSD5030R2022-12-08
10891153001962TempoSD5030O2022-12-08
10891153001986TempoSD5030BEA2022-12-08
00857425005635Select ChoiceGAU21022022-12-08
00891153001194Tempo22042022-12-08
00891153001200Tempo44042022-12-08
00891153001217Tempo33042022-12-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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