Catalog Number

-

Brand Name

Endo SmartCap

Version/Model Number

100164U

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

-

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

30bccf3d-f7b1-4522-b023-75f2e7891616

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

April 30, 2020

Package DI Number

40677964013728

Quantity per Package

10

Contains DI Package

00677964111051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-