Catalog Number

126035180

Brand Name

WORKER™ Guidewire

Version/Model Number

126035180

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160785,K160785

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

954a815d-aa21-47c9-9b65-354b176a6101

Public Version Date

September 24, 2018

Public Version Number

1

DI Record Publish Date

August 24, 2018

Package DI Number

20886333224580

Quantity per Package

10

Contains DI Package

00886333224586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box