Catalog Number

SGW-055-46

Brand Name

Guidewire

Version/Model Number

SGW-055-46

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2020

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"

Yes

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

K021990,K021990,K021990

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

f976af18-b334-47ab-9d90-880a09813c7f

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

February 06, 2018

Package DI Number

20841268107278

Quantity per Package

25

Contains DI Package

10841268107271

Package Discontinue Date

December 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipper Box