Identity
- Trade Name
- Kendall™ FDA UDI
- Generic Name
- Torque manipulation device FDA UDI
- Device Name
- GW WWTD35001 WHOLEY WIRE V02 FDA UDI
- Model / Reference
- WWTD35001 FDA UDI
- Description
- GW WWTD35001 WHOLEY WIRE V02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684058596 FDA UDI
- 510(k) Number
- K120863 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Torque manipulation device
Kendall™ by Covidien LP — 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
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- 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
K120863 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 1f18eaf9-6b1d-4710-86fb-8920b357246b 37 fields · synced May 30, 2026