FDA.reportPublic FDA data

TRAUMA BANDAGE

Primary DI
07611600953608
Brand
TRAUMA BANDAGE
Company
IVF HARTMANN AG
Model
831273 TRAUMA BANDAGE 10 cm
Device description
TRAUMA BANDAGE 10 cm
Published
2023-08-09
Public version status
Update
Distribution status
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
GAXTourniquet, Nonpneumatic
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611600986668PackageGS1130In Commercial Distribution
07611600953608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611600986668076116009866687611600986668
07611600953608076116009536087611600953608

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
482173783
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07611600953684TRAUMA BANDAGE831274 TRAUMA BANDAGE 15 cm2023-08-09
07611600953677TRAUMA BANDAGE831275 TRAUMA BANDAGE 20 cm2023-08-09
07611600986767TRAUMA BANDAGE831274 TRAUMA BANDAGE 15 cm2023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40888277362261MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-06-09
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
M68932700080BATTLE BANDAGESafeguard US Operating, LLCMHW2025-08-01
10884450828752SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-07-01
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
10884450844240SAFEGUARD FOCUS COOL™Merit Medical Systems, Inc.MHW2025-03-07
M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
10884450828745SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
19555240404098ITL Essentials™ Tourniquet B&B Thick Strap 45cm NSITL ASIA PACIFIC SDN. BHD.GAX2023-12-11
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
10811331010180Comfort BandTz Medical, Inc.MHW2023-10-20
10665973022410DukalDukal LLCGAX2023-05-30
10665973031429DukalDukal LLCGAX2023-05-30
10665973031436DukalDukal LLCGAX2023-05-30
10665973031443DukalDukal LLCGAX2023-05-30
10665973031450DukalDukal LLCGAX2023-05-30
10665973031467DukalDukal LLCGAX2023-05-30
10665973031474DukalDukal LLCGAX2023-05-30
10665973031481DukalDukal LLCGAX2023-05-30