Catalog Number

-

Brand Name

Uscope

Version/Model Number

PU3022A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K172098,K172098

Product Code

FGB

Product Code Name

Ureteroscope And Accessories, Flexible/Rigid

Public Device Record Key

0967ca09-326c-4f68-9be5-18eca4c4c2d2

Public Version Date

December 06, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2017

Package DI Number

16971176280026

Quantity per Package

1

Contains DI Package

06971176280029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX