FDA.reportPublic FDA data

Fisherbrand

Primary DI
20613647020511
Brand
Fisherbrand
Company
FISHER SCIENTIFIC COMPANY L.L.C.
Model
22415468
Catalog number
22415468
Device description
GAUZE PAD ST 3X3 12PLY 100/PK
Published
2022-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
20613647020511PackageGS11In Commercial Distribution
30613647020518PackageGS124In Commercial Distribution
00613647020517PrimaryGS10
10613647020514Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061364702051120613647020511
3061364702051830613647020518
00613647020517006136470205176136470205170613647020517
1061364702051410613647020514

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

Contacts#

Phone, Email table
PhoneEmail
+1(724)517-2425regulatory.affairs@thermofisher.com

Regulatory Flags#

DUNS number
004321519
Device count
100
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
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
00613647028346Fisherbrand11002204110022042025-06-30
00613647028674Fisherbrand13-711-274MD13711274MD2025-06-30
00613647028681Fisherbrand13-711-336MD13711336MD2025-06-30
00613647028698Fisherbrand13-711-5AMMD137115AMMD2025-06-30
00613647028711Fisherbrand13-711-9AMMD137119AMMD2025-06-30
20613647028340Fisherbrand11002204110022042025-06-30
20613647028678Fisherbrand13-711-274MD13711274MD2025-06-30
20613647028685Fisherbrand13-711-336MD13711336MD2025-06-30
30613647028699Fisherbrand13-711-5AMMD137115AMMD2025-06-30
30613647028712Fisherbrand13-711-9AMMD137119AMMD2025-06-30
00613647029855Fisherbrand121011F2141270512025-06-30
00613647029862Fisherbrand120953F141275542025-06-30
00613647010907FisherbrandSC-150-100135001002025-04-30
00613647010914FisherbrandSC-180-100135001012025-04-30
00613647010921FisherbrandSC-220-100135001022025-04-30
00613647010938FisherbrandSC-250-100135001032025-04-30
00613647018842Fisherbrand23101000231010002025-04-30
00613647018859Fisherbrand23101001231010012025-04-30
00613647018866Fisherbrand23101002231010022025-04-30
00613647018873Fisherbrand23101003231010032025-04-30

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G242YCDAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
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G242YCAAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
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G242YCALMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAMMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCANMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAQMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCARMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCATMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAWMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAXMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05