Catalog Number

HFH12

Brand Name

Prosurg

Version/Model Number

HFH12

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

K120766,K120766

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

ba4b4c00-79f4-4900-876c-573d13ef191c

Public Version Date

May 29, 2020

Public Version Number

1

DI Record Publish Date

May 21, 2020

Package DI Number

10851545007835

Quantity per Package

1

Contains DI Package

00851545007838

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pak