Identity
- Trade Name
- Wholey™ FDA UDI
- Generic Name
- Peripheral vascular guidewire extension FDA UDI
- Device Name
- GW WWES35001 WHOLEY WIRE V03 FDA UDI
- Model / Reference
- WWES35001 FDA UDI
- Description
- GW WWES35001 WHOLEY WIRE V03 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684058725 FDA UDI
- 510(k) Number
- K120863 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Peripheral vascular guidewire extension 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
Dimensions & Sizes
- Size
- Length — 155 Centimeter FDA UDI
Category: Peripheral vascular guidewire extension
Wholey™ by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular guidewire extension.
- LOC — Abbott Vascular · Class II
- Traxcess Docking Wire — MICROVENTION INC. · Class II
- Wholey™ — EV3, INC · Class II
- EXTENSION — ASAHI INTECC CO., LTD. · Class II
- Wholey™ — Covidien LP · Class II
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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI c0f88c08-296c-4743-ae0d-f0a8b0a66b7c 37 fields · synced May 31, 2026