FDA.reportPublic FDA data

MiniTAC Gauze

Primary DI
M689HHMTG01020
Brand
MiniTAC Gauze
Company
Safeguard US Operating, LLC
Model
02
Catalog number
HHMTG01
Device description
The mini-TAC Gauze is apart the TACGauze Family of Products are to be used by emergency medical personnel in the Battle Field/or Pre-hospital. This smaller version of the TACGauze is a sterile non-woven cotton gauze.
Published
2026-10-13
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
M689HHMTG01020PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedical.com

Regulatory Flags#

DUNS number
118492643
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Primary DI, Brand, Model table
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M68981605020K9 Trauma Kit0281-6052026-08-25
M68987155030TX Bleeding Control Kit - Advanced0387-1552026-08-25
M68987232010Stop the Bleed Kit (NJSP)0187-2322026-08-25
M689SDREDC1OTC010SDR-EDC1OTC01SDR-EDC1OTC2026-08-25
M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTC02SDR-TBBOTC2026-08-25
M689HHSCK01EA020Simplified Cricothyrotomy Kit02HHSCK01-EA2022-08-10
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Primary DI, Brand, Company table
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D832SAPR21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR31PlasdentPLASDENT CORPORATIONNAB2026-10-13
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
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10885380207174CurityCardinal Health 200, LLCNAB2026-10-08
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00840456224205JMUJMU DENTAL, INCNAB2026-06-23