Catalog Number

-

Brand Name

ENDO SMARTCAP

Version/Model Number

100145CO2EXT

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

f6541f75-29ba-4095-a3ae-bde5a703730b

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

September 22, 2016

Package DI Number

20677964059081

Quantity per Package

50

Contains DI Package

00677964059087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case