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Jetwire

FDA UDI

Class II (US FDA UDI)

by Bayer Healthcare

Identity

Trade Name
JETWIRE FDA UDI
Generic Name
Peripheral vascular guidewire, manual FDA UDI
Device Name
JETSTREAM GUIDEWIRE FDA UDI
Model / Reference
011525-001 FDA UDI
Description
JETSTREAM GUIDEWIRE FDA UDI

Identifiers

Catalog Number
011525 FDA UDI
Primary DI / UDI-DI
00616258005164 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

Yes

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
Length — .014 Inch FDA UDI

Category: Peripheral vascular guidewire, manual

Jetwire by Bayer Healthcare — 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
Bayer Healthcare

Sources (1)

  • FDA UDI 89b23d71-6246-4d58-9e15-21411e4241e2 35 fields · synced Jun 8, 2026