Catalog Number

-

Brand Name

NA

Version/Model Number

AG-5453-13-15-18

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)

Yes

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

K200173,K200173,K200173

Product Code

GCA

Product Code Name

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Public Device Record Key

6a417f86-13ab-40d6-8d90-202210d7c7a5

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 09, 2022

Package DI Number

16959664910754

Quantity per Package

5

Contains DI Package

06959664910757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box