Identity
- Trade Name
- ADx FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- GUIDEWIRE, PTFE 035 X 180CM FC ST BENTSON FDA UDI
- Model / Reference
- 814135180 FDA UDI
- Description
- GUIDEWIRE, PTFE 035 X 180CM FC ST BENTSON FDA UDI
Identifiers
- Primary DI / UDI-DI
- H7878141351800 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
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 180 Centimeter FDA UDIOuter Diameter — 0.035 Inch FDA UDI
ADx by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Angiodynamics, Inc.
Sources (1)
- FDA UDI 96a12c9a-3ceb-4057-b93e-6dcab603ab3d 36 fields · synced Jun 8, 2026