Catalog Number

0233032890

Brand Name

Uro/Gyn Accessories

Version/Model Number

0233032890

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

-

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

K043021

Product Code

FGB

Product Code Name

Ureteroscope and accessories, flexible/rigid

Public Device Record Key

5dcf7543-80e9-4bdf-9ce2-e6d2470e7788

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

May 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-