Catalog Number

-

Brand Name

NA

Version/Model Number

AG-5063-S2524G

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

K201509,K201509,K201509

Product Code

LQR

Product Code Name

Dislodger, Stone, Biliary

Public Device Record Key

390ba6b8-16df-46cd-9fc0-8c5a035fbc6e

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 09, 2022

Package DI Number

16959664900830

Quantity per Package

10

Contains DI Package

06959664900833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box