Catalog Number

08-5102

Brand Name

EndoSheath Technology

Version/Model Number

CV-1.5

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072180,K072180

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

13281a34-6701-4c43-9f9a-233f66d84ee5

Public Version Date

November 10, 2021

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

20874485000824

Quantity per Package

10

Contains DI Package

00874485003173

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-