Catalog Number

SW30-140J

Brand Name

Guidewire

Version/Model Number

SGW-057-08

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"

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

d1b41e05-bc43-4110-a09e-92798761946b

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

August 09, 2017

Package DI Number

10841268106878

Quantity per Package

10

Contains DI Package

00841268106871

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box