Catalog Number

GU6384

Brand Name

V. Mueller

Version/Model Number

GU6384

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 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"

-

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

-

Product Code

FFL

Product Code Name

DISLODGER, STONE, BASKET, URETERAL, METAL

Public Device Record Key

cb536a9a-146c-4b4f-9bfd-e812a4e14359

Public Version Date

March 07, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-