Catalog Number

-

Brand Name

DISPOCAP

Version/Model Number

100160P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 21, 2018

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

K093665,K093665

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

b43cd098-a172-418f-9c1f-bcf5b5ce58fe

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-