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Flexura Guidewire

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
Flexura Guidewire FDA UDI
Generic Name
Peripheral vascular guidewire, manual FDA UDI
Device Name
Flexura Guidewire,s/a FDA UDI
Model / Reference
3775550 FDA UDI
Description
Flexura Guidewire,s/a FDA UDI

Identifiers

Catalog Number
3775550 FDA UDI
Primary DI / UDI-DI
00801741086922 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Peripheral vascular guidewire, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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 — 0.018 Inch FDA UDI
Length — 50 Centimeter FDA UDI

Category: Peripheral vascular guidewire, manual

Flexura Guidewire by Bard Access Systems, 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
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI 390b4cc5-e068-473b-8b1e-52714739f82f 36 fields · synced Jun 9, 2026