Catalog Number

-

Brand Name

ENDO SMARTCAP

Version/Model Number

100141

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)

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

55f79cb2-1b43-42fe-b603-6eace072a48e

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

September 22, 2016

Package DI Number

20677964059456

Quantity per Package

50

Contains DI Package

00677964059452

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case