Identity
- Trade Name
- Tourniquet Hoses EUDAMEDOrantech FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Tourniquet Hoses EUDAMEDZimmer Biomet Compatible Tourniquet dual hoses set of Blue dual hose/4m and Red dual hose/4m FDA UDI
- Model / Reference
- TH-DD40-4949-4848 EUDAMEDFDA UDI
- Description
- Zimmer Biomet Compatible Tourniquet dual hoses set of Blue dual hose/4m and Red dual hose/4m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691965510 EUDAMEDFDA UDI
- Basic UDI-DI
- 69416919ORANTECH18R8 EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- C900180 HAEMOSTASIS SYSTEMS - ACCESSORIES EUDAMED
- GMDN Term
- Tourniquet cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tourniquet Hoses by Orantech Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69416919ORANTECH18R8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orantech Inc.
- EUDAMED SRN
- CN-MF-000013859
- Authorised Representative
- Medten EU ApS DK-AR-000034434
Sources (2)
- EUDAMED fc14e234-3d44-4ab5-b4f6-660f33308902 61 fields · synced Jul 14, 2026
- FDA UDI 5f37a91a-c260-40f7-87f1-1640fced7871 33 fields · synced May 30, 2026