FDA.reportPublic FDA data

TRAUMA BANDAGE

Primary DI
07611600986767
Brand
TRAUMA BANDAGE
Company
IVF HARTMANN AG
Model
831274 TRAUMA BANDAGE 15 cm
Device description
TRAUMA BANDAGE 15 cm
Published
2023-08-09
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

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
07611600986767PackageGS187In Commercial Distribution
07611600953684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611600986767076116009867677611600986767
07611600953684076116009536847611600953684

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
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07611600953684TRAUMA BANDAGE831274 TRAUMA BANDAGE 15 cm2023-08-09
07611600953608TRAUMA BANDAGE831273 TRAUMA BANDAGE 10 cm2023-08-09
07611600953677TRAUMA BANDAGE831275 TRAUMA BANDAGE 20 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