Catalog Number

-

Brand Name

ClearPetra

Version/Model Number

90132024

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)

Yes

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

K161110,K161110,K161110

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

d28a22f2-2937-4b97-a29d-4ce09593555f

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 14, 2021

Package DI Number

16944932748146

Quantity per Package

1

Contains DI Package

06944932748149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box