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ADx

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc.

Identity

Trade Name
ADx FDA UDI
Generic Name
Peripheral vascular guidewire, manual FDA UDI
Device Name
GUIDEWIRE, PTFE 038 X 80CM FC 3MM J FDA UDI
Model / Reference
810538080 FDA UDI
Description
GUIDEWIRE, PTFE 038 X 80CM FC 3MM J FDA UDI

Identifiers

Primary DI / UDI-DI
H7878105380800 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

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
Outer Diameter — 0.038 Inch FDA UDI
Length — 80 Centimeter FDA UDI

Category: Peripheral vascular guidewire, manual

ADx by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular guidewire, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA UDI ebeaf3d7-c824-42fe-8266-af337c272ab5 35 fields · synced Jun 8, 2026