FDA UDI
In Commercial Distribution
🇺🇸 United States
DynaSafety Trauma2 Tourniquets
DI: 00840117336469
·
Model: 3135
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- DynaSafety Trauma2 Tourniquets
- Primary DI
- 00840117336469
- Version / Model
- 3135
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-06-17
- Public Version
- 3
- Public Version Date
- 2024-10-10
- Public Version Status
- Update
- Public Device Record Key
- 72a6e725-154f-4820-bb33-9b304c5f69a9
Device Description
Non-Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 67046 | Arterial tourniquet, manual, single-use | A device in the form of a band or strap intended to be wrapped and manually tightened around a patient's limb (arm or leg) to control/stop life-threatening (emergency) bleeding from an artery (e.g., in a military setting and/or high-risk work environment). It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810180840118 | GS1 | ||||
| Primary | 00840117336469 | GS1 |