FDA.reportPublic FDA data

ProStat

Primary DI
00814889011930
Brand
ProStat
Company
Prostat First Aid, LLC
Model
2508
Device description
"GUAZE ROLL 3"" NS"
Published
2023-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00814889011930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814889011930008148890119308148890119300814889011930

GMDN Terms#

Term, Definition table
TermDefinition
First aid absorbent pad/bandageA wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. 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
No natural rubber latex
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
00814889010643ProStat22062022-10-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832CFT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832FT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP31PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR31PlasdentPLASDENT CORPORATIONNAB2026-10-13
M689HHMTG01020MiniTAC GauzeSafeguard US Operating, LLCNAB2026-10-13
00050428143117CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428339763CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428343869CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
10885380207150CurityCardinal Health 200, LLCNAB2026-10-08
10885380207167CurityCardinal Health 200, LLCNAB2026-10-08
10885380207174CurityCardinal Health 200, LLCNAB2026-10-08
50885380207202CurityCardinal Health 200, LLCNAB2026-10-08
50885380207219CurityCardinal Health 200, LLCNAB2026-10-08
50885380207226CurityCardinal Health 200, LLCNAB2026-10-08
50885380207233CurityCardinal Health 200, LLCNAB2026-10-08
50885380207240CurityCardinal Health 200, LLCNAB2026-10-08
50885380207257CurityCardinal Health 200, LLCNAB2026-10-08
06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
00810194401671AiraAIRA, LLCNAB2026-08-26
06979931947972TempoXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-08-21
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