Identity
- Trade Name
- Wallstent FDA UDI
- Generic Name
- General-purpose non-vascular guidewire FDA UDI
- Device Name
- WALLSTENT SS guidewire .035" B/5 FDA UDI
- Model / Reference
- H965180011 FDA UDI
- Description
- WALLSTENT SS guidewire .035" B/5 FDA UDI
Identifiers
- Catalog Number
- H965180011 FDA UDI
- Primary DI / UDI-DI
- 08714729203070 FDA UDI
- FDA Product Code
- OCY FDA UDI
- GMDN Term
- General-purpose non-vascular guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Dimensions & Sizes
- Size
- Outer Diameter — 0.035 Inch FDA UDI
Category: General-purpose non-vascular guidewire
Wallstent by Lake Region Medical — 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
- 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
- GLIDEWIRE — Terumo Corp. · 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
- Lake Region Medical
Sources (1)
- FDA UDI 0aea76a1-ab4d-4784-a13e-836ad1516cc1 36 fields · synced Jun 9, 2026