FDA UDI
In Commercial Distribution
🇺🇸 United States
Tournisec
DI: 00199874682402
·
Model: KFG112
·
62K SOLUTIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Tournisec
- Primary DI
- 00199874682402
- Version / Model
- KFG112
- Company Name
- 62K SOLUTIONS, LLC
- Labeler DUNS
- 129718808
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-12-15
- Public Version
- 1
- Public Version Date
- 2025-12-23
- Public Version Status
- New
- Public Device Record Key
- 3c78a628-bb3c-45c6-8dd7-ae5361c8c853
Device Description
10 Pack - Disposable, non-sterile, single use, form fitting, stockinette worn by patient that acts as padding and method of securing a pneumatic tourniquet at the thigh. Large size (12" width). Waist size > or = 36".
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
- 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 |
|---|---|---|---|---|
| ILG | Stocking, Elastic | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31724 | Tubular support bandage, non-latex, single-use | A tubular elastic non-latex fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). 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 | 10199874723973 | GS1 | ||||
| Primary | 00199874682402 | GS1 |
Customer Contacts
- Phone
- 9788917836
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 12 | Inch |