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Worker™ Guidewire

FDA UDI

Class II (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name
Worker™ Guidewire FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
Worker™ Guidewire Amplatz J Curve 0.035"/150cm/7.5cm FDA UDI
Model / Reference
114235150 FDA UDI
Description
Worker™ Guidewire Amplatz J Curve 0.035"/150cm/7.5cm FDA UDI

Identifiers

Catalog Number
114235150 FDA UDI
Primary DI / UDI-DI
00886333008117 FDA UDI
510(k) Number
K160785 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use 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

Yes

FDA UDI

Worker™ Guidewire by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160785 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (1)

  • FDA UDI c86a7745-985e-4702-9e00-9786fc0b6609 38 fields · synced Jun 9, 2026