Catalog Number

20.SA65

Brand Name

NA

Version/Model Number

20SA65

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FAJ

Product Code Name

Cystoscope and accessories, flexible/rigid

Public Device Record Key

6d4e7cdb-05ee-4392-b5fd-a87073177d9a

Public Version Date

April 20, 2022

Public Version Number

2

DI Record Publish Date

March 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-