Identity
- Trade Name
- Orantech FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Reusable cylindrical tourniquet Cuffs,12"X3.5",dual port,single bladder,dark purple FDA UDI
- Model / Reference
- TNC-GPS-CTC-004 FDA UDI
- Description
- Reusable cylindrical tourniquet Cuffs,12"X3.5",dual port,single bladder,dark purple FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06941691969044 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Tourniquet cuff, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5910 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
Yes
FDA UDI
Category: Tourniquet cuff, reusable
Orantech by Orantech Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, reusable.
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- Reusable Conical Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Easi-Fit BFR, Reusable — Delfi Medical Innovations Inc · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
- Vari-Fit Reusable — Delfi Medical Innovations Inc · 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 |
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Manufacturer
- Manufacturer
- Orantech Inc.
Sources (1)
- FDA UDI 2b297a2d-ac57-4fb2-9580-9793332cdcbc 33 fields · synced Jun 8, 2026