Identity
- Trade Name
- Flex-Ez Guidewire FDA UDI
- Generic Name
- General-purpose non-vascular guidewire FDA UDI
- Device Name
- A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device FDA UDI
- Model / Reference
- 3406 FDA UDI
- Description
- A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device FDA UDI
Identifiers
- Catalog Number
- 3406 FDA UDI
- Primary DI / UDI-DI
- M84934060 FDA UDI
- 510(k) Number
- K914358 FDA UDI
- FDA Product Code
- EYB FDA UDI
- GMDN Term
- General-purpose non-vascular guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
Yes
FDA UDI
Category: General-purpose non-vascular guidewire
Flex-Ez Guidewire by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose non-vascular guidewire.
- Jagwire — Boston Scientific · Class II
- GUIDE WIRE M — Terumo Corp. · Class II
- GLIDEWIRE — Terumo Corp. · Class II
- PTFE Coated Urological Guidewire — Lake Region Medical · Class I
- RX Cholangiogram Kit — Boston Scientific · Class II
- PTFE Coated Urological Guidewire — LAKE REGION MEDICAL LIMITED · Class I
- GLIDEWIRE — Terumo Corp. · Class II
- GLIDEWIRE — Terumo Corp. · Class II
Cleared under the same submission
K914358 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
- Hobbs Medical, Inc.
Sources (1)
- FDA UDI 4b631ea1-b11a-43dd-9378-aebd997b2144 36 fields · synced May 30, 2026