FDA UDI
In Commercial Distribution
🇺🇸 United States
Tourniquets
DI: 00810050855556
·
Model: TQ0202N
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
125
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Basic Information
- Brand Name
- Tourniquets
- Primary DI
- 00810050855556
- Version / Model
- TQ0202N
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 125
- Record Status
- Published
- Publish Date
- 2024-04-25
- Public Version
- 1
- Public Version Date
- 2024-05-03
- Public Version Status
- New
- Public Device Record Key
- 9d651727-75a5-415d-a516-f4b31e8204d3
Device Description
Tourniquet 3/4" x 18", Textured, Rolled & Banded, Orange
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
- No
- 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 |
|---|---|---|---|---|
| 47949 | Tourniquet cuff bandage, non-latex | A sterile strip or roll of non-latex containing material that is applied around an extremity (arm or leg) before the fitting of a tourniquet cuff on top of it. This device is used to protect the patient's skin from wrinkling, pinching or shearing and to protect the tourniquet cuff from becoming soiled with blood and other fluids from the operative site. It would typically be folded back over the exposed edges of the cuff to provide maximum protection. 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 | 00810050855549 | GS1 | ||||
| Primary | 00810050855556 | GS1 |