Identity
- Trade Name
- Tourni-Cot - Medium FDA UDI
- Generic Name
- Digit tourniquet, manual FDA UDI
- Device Name
- Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes. FDA UDI
- Model / Reference
- TCM FDA UDI
- Description
- Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855364004047 FDA UDI
- 510(k) Number
- K853472 FDA UDI
- FDA Product Code
- GAX FDA UDI
- GMDN Term
- Digit tourniquet, manual 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Digit tourniquet, manual
Tourni-Cot - Medium by Mar-Med Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Digit tourniquet, manual.
- T-RING FLEX Digit Tourniquet — Precision Medical Devices Inc · Class I
- T-RING Digit Tourniquet — Precision Medical Devices Inc · Class I
- Susol® Ribbon Tourniquet — BAILEY INSTRUMENTS LTD · Class I
- Tourni-Cot - Large — Mar-Med Co. · Class I
- Tourni-Cot - Small — Mar-Med Co. · Class I
- Tourni-Cot - Extra Large — Mar-Med Co. · Class I
- Tourni-Cot - Universal — Mar-Med Co. · Class I
Cleared under the same submission
K853472 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mar-Med Co.
Sources (1)
- FDA UDI 17a62c5a-19a1-4bef-b418-4fefe098b2d3 35 fields · synced May 30, 2026