Catalog Number

SGW-015-08

Brand Name

Guidewire

Version/Model Number

SGW-015-08

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

K982559,K982559,K982559

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

ffc3c65e-3832-446b-8e23-217c90b8af2e

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

October 29, 2021

Package DI Number

10841268109626

Quantity per Package

10

Contains DI Package

00841268109629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box