Identity
- Trade Name
- TK-4 Elastic Tourniquet FDA UDI
- Generic Name
- Limb tourniquet, manual, single-use FDA UDI
- Device Name
- TK-4 Tourniquet, an elastic tourniquet with two S-hook ends, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss. Strap color is coyote tan FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TK-4 Tourniquet, an elastic tourniquet with two S-hook ends, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss. Strap color is coyote tan FDA UDI
Identifiers
- Catalog Number
- TK-4 FDA UDI
- Primary DI / UDI-DI
- 00857048006316 FDA UDI
- FDA Product Code
- GAX FDA UDI
- GMDN Term
- Limb tourniquet, manual, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Limb tourniquet, manual, single-use
TK-4 Elastic Tourniquet by H & H Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- H & H Medical Corporation
Sources (1)
- FDA UDI 1f5216f0-8c0b-4014-9f40-4b0616ddec88 35 fields · synced May 31, 2026