Identity
- Trade Name
- RADIFOCUS FDA UDI
- Generic Name
- Torque manipulation device FDA UDI
- Device Name
- Torque Device FDA UDI
- Model / Reference
- XX*RF02AH FDA UDI
- Description
- Torque Device FDA UDI
Identifiers
- Catalog Number
- TD01 FDA UDI
- Primary DI / UDI-DI
- 36927675513480 FDA UDI
- 510(k) Number
- K220934 FDA UDI
- FDA Product Code
- MOF FDA UDIPTL 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
Radifocus by Terumo Medical Products (Hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Torque manipulation device.
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- Cook — COOK INCORPORATED · Class I
- Torque Device for Guidewire — Amsinomed Medical Co., 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 II | Pending data |
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Manufacturer
- Manufacturer
- Terumo Medical Products (Hangzhou) Co., Ltd.
Sources (1)
- FDA UDI f1176292-525c-49ef-9de2-7b1619917dec 37 fields · synced May 30, 2026