Identity
- Trade Name
- SPINR FDA UDI
- Generic Name
- Torque manipulation device FDA UDI
- Device Name
- Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature FDA UDI
- Model / Reference
- SPN-1005 FDA UDI
- Description
- Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature FDA UDI
Identifiers
- Catalog Number
- SPN-1005 FDA UDI
- Primary DI / UDI-DI
- B090SPN10050 FDA UDI
- 510(k) Number
- K141054 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Torque manipulation device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Torque manipulation device
Spinr by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Torque manipulation device.
- Olcott — COOK INCORPORATED · Class II
- NAMIC — NAVILYST MEDICAL, INC. · Class II
- VSZL — TELEFLEX INCORPORATED · Class II
- Torque Device for Guidewire — Amsinomed Medical Co., Ltd · Class I
- Torque Device for Guidewire — Amsinomed Medical Co., Ltd · Class I
- K2M General Instruments — K2M, INC. · Class I
- Cook — COOK INCORPORATED · Class I
- Torque Device for Guidewire — Amsinomed Medical Co., Ltd · Class I
Cleared under the same submission
K141054 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 II | Pending data |
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Manufacturer
- Manufacturer
- ZIEN Medical Technologies, LLC
Sources (1)
- FDA UDI 7708e192-1c91-4027-a032-c84ac9c32a71 35 fields · synced Jun 6, 2026