FDA.reportPublic FDA data

BATTLE BANDAGE

Primary DI
M68932700030
Brand
BATTLE BANDAGE
Company
Safeguard US Operating, LLC
Model
03
Catalog number
32-700
Device description
"Battle Bandage1 ea. - 8"" x 8"", sterile gauze pad with 6' x 4"", clear, self adhering, compression wrap"
Published
2019-12-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68932700030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, non-medicated, sterileA collection of sterile instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true
Kit
true

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M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
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M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

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