FDA.reportPublic FDA data

ProStat

Primary DI
00814889010643
Brand
ProStat
Company
Prostat First Aid, LLC
Model
2206
Device description
"GAUZE PADS STERILE 3"" x 3"""
Published
2022-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00814889010643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814889010643008148890106438148890106430814889010643

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze pad, non-antimicrobialA 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
117129815
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814889016782ProStat70422026-05-08
00814889016492ProStat0164072025-09-03
00814889010599ProStat25922025-07-02
00814889010605ProStat20422025-07-02
00814889010629ProStat22792025-07-02
00814889010131ProStat20082022-10-27
00814889010698ProStat20382022-10-27
00814889010803ProStat21952022-10-27
00814889010810ProStat21982022-10-27
00814889010827ProStat21962022-10-27
00814889010834ProStat21942022-10-27
00814889010841ProStat21972022-10-27
00814889016348ProStat20962025-02-24
00814889016355ProStat21482025-02-24
00814889016362ProStat22942025-02-24
00814889014771Front LineFL20082023-11-03
00814889016331ProStat20822025-02-24
00814889016379ProStat20252025-02-24
00814889010865ProStat22702024-08-22
00814889010872ProStat22712024-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
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G242YCAPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
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G242YCATMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05