Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- Double Flexible Tipped Wire Guide FDA UDI
- Model / Reference
- G01306 FDA UDI
- Description
- Double Flexible Tipped Wire Guide FDA UDI
Identifiers
- Catalog Number
- TDOC-35-145-0-1.5 FDA UDI
- Primary DI / UDI-DI
- 00827002013063 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Peripheral vascular guidewire, manual 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Peripheral vascular guidewire, manual
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Peripheral vascular guidewire, manual.
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- ASAHI Gladius14 — ASAHI INTECC CO., LTD. · Class II
- Cardio Flow Peripheral Guide Wire — Cardio Flow Inc., · Class II
- Merit Laureate® — Merit Medical Systems, Inc. · Class II
- Nit-Vu — ANGIODYNAMICS, INC · Class II
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
- Cook Incorporated
Sources (1)
- FDA UDI 66e2a125-efeb-4d5a-aa59-349cca1f9043 36 fields · synced Jun 8, 2026