Catalog Number

-

Brand Name

PENTAX ENDO SMARTCAP

Version/Model Number

100551P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 03, 2022

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

6014cdde-12af-4411-8d94-715e9af12bf4

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

October 10, 2018

Package DI Number

20677964060315

Quantity per Package

40

Contains DI Package

00677964060311

Package Discontinue Date

May 03, 2022

Package Status

Not in Commercial Distribution

Package Type

Case