Catalog Number

-

Brand Name

ClearPetra

Version/Model Number

90111126

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

K161110,K161110,K161110

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

38ef97b1-051d-43e1-a0fa-5d7ea3c44795

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Package DI Number

16944932740034

Quantity per Package

5

Contains DI Package

06944932740037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box