Catalog Number

49-228

Brand Name

Starter™ Guidewire

Version/Model Number

M001492281

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

-

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

bbc3e0c2-9907-4e2f-a22f-7beb5b988566

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

November 10, 2016

Package DI Number

08714729743712

Quantity per Package

10

Contains DI Package

08714729327141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-