FDA UDI
In Commercial Distribution
🇺🇸 United States
TRAUMA BANDAGE
DI: 07611600953608
·
Model: 831273 TRAUMA BANDAGE 10 cm
·
IVF HARTMANN AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TRAUMA BANDAGE
- Primary DI
- 07611600953608
- Version / Model
- 831273 TRAUMA BANDAGE 10 cm
- Company Name
- IVF HARTMANN AG
- Labeler DUNS
- 482173783
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-09
- Public Version
- 1
- Public Version Date
- 2023-08-17
- Public Version Status
- New
- Public Device Record Key
- 1d961685-b929-4f41-89ce-ceb7b79d9c21
Device Description
TRAUMA BANDAGE 10 cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47011 | First aid absorbent pad/bandage | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07611600953608 | GS1 | ||||
| Package | 07611600986668 | GS1 | CS | 130 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 50 Degrees Celsius