Catalog Number

-

Brand Name

GynoVision

Version/Model Number

JSX-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 01, 2030

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K172151

Product Code

HGH

Product Code Name

Cannula, Suction, Uterine

Public Device Record Key

4ee7b050-99c6-4658-bea3-761870d22f77

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-