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Tourni-Cot - Extra Large
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TXL
by Mar-Med Co.
Identity
- Trade Name
- Tourni-Cot Extra Large EUDAMEDTourni-Cot - Extra Large FDA UDI
- Generic Name
- Digit tourniquet, manual FDA UDI
- Device Name
- Tourni-Cot Extra Large EUDAMEDExsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes. FDA UDI
- Model / Reference
- TXL EUDAMEDFDA UDI
- Description
- Exsanguinating digital tourniquets to create a bloodless field for procedures on fingers and toes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855364004061 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855364004061 EUDAMED
- 510(k) Number
- K853472 FDA UDI
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Digit tourniquet, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 - Extra Large by Mar-Med Co. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 - Medium — Mar-Med Co. · Class I
- Tourni-Cot - Large — Mar-Med Co. · Class I
- Tourni-Cot - Small — Mar-Med Co. · Class I
- Tourni-Cot - Universal — Mar-Med Co. · Class I
Cleared under the same submission
K853472 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| 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 (2)
- FDA UDI fda825a9-4414-4f01-8758-752751170653 35 fields · synced Jul 16, 2026
- EUDAMED 7e7a4004-ac99-45fd-981b-30a69b50e8a2 61 fields · synced Jul 16, 2026