Identity
- Trade Name
- Seraket® Tourniquet FDA UDI
- Generic Name
- Limb tourniquet, manual, reusable FDA UDI
- Device Name
- Tourniquet, Quick Release Buckle Tourniquet FDA UDI
- Model / Reference
- blue FDA UDI
- Description
- Tourniquet, Quick Release Buckle Tourniquet FDA UDI
Identifiers
- Catalog Number
- 5000K415A FDA UDI
- Primary DI / UDI-DI
- 04250373651286 FDA UDI
- FDA Product Code
- GAX FDA UDI
- GMDN Term
- Limb tourniquet, manual, reusable 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Limb tourniquet, manual, reusable
Seraket® Tourniquet by Kimetec GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Limb tourniquet, manual, reusable.
- 10 cm x 3, 5 mt. İdeal Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
- 15 cm x 5 mt. Elastik Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
- Opaska zaciskowa — ChM spółka z ograniczoną odpowiedzialnością · Class I
- 15 cm x 5 mt. Ten Rengi İdeal Bandaj — TEMAŞ TIBBİ MALZEMELER VE SARGI BEZİ SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class I
- TOURNIQUET — ZHENGZHOU MEDCONS IMPORT&EXPORT TRADING CO.,LTD · Class I
- garrot militaire combat application toueniquet — Danyang Sunmed Healthcare Corporation · Class I
- Constricting band — EMSRUN GROUP · Class I
- 200 Single use tourniquets InControl brand — ASEP HEALTHCARE LTD · Class I
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
- Kimetec GmbH
Sources (1)
- FDA UDI 8d837b83-61ae-4178-bce6-6e2c4c437700 34 fields · synced Jun 7, 2026