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Enteer™

FDA UDI

Class II (US FDA UDI)

by Ev3, Inc

Identity

Trade Name
Enteer™ FDA UDI
Generic Name
Peripheral vascular guidewire, manual FDA UDI
Device Name
GW ENW-SD-014-300 CTO RE-ENTRY V03 FDA UDI
Model / Reference
ENW-SD-014-300 FDA UDI
Description
GW ENW-SD-014-300 CTO RE-ENTRY V03 FDA UDI

Identifiers

Primary DI / UDI-DI
00821684073834 FDA UDI
510(k) Number
K120533 FDA UDI
FDA Product Code
PDU FDA UDI
GMDN Term
Peripheral vascular guidewire, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 300.0 Centimeter FDA UDI
Outer Diameter — 0.36 Millimeter FDA UDI

Category: Peripheral vascular guidewire, manual

Enteer™ by Ev3, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular guidewire, manual.

Cleared under the same submission

K120533 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ev3, Inc

Sources (1)

  • FDA UDI ed744771-ea10-4fb2-b6e5-4c74435e0f3e 37 fields · synced May 31, 2026