Catalog Number

-

Brand Name

GynoVision

Version/Model Number

JSX-T-8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 30, 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

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

K172151,K172151,K172151

Product Code

HGH

Product Code Name

Cannula, Suction, Uterine

Public Device Record Key

d06daf15-6fdb-4410-80a4-5affda13c762

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

06946332802261

Quantity per Package

10

Contains DI Package

06946332802254

Package Discontinue Date

August 01, 2020

Package Status

Not in Commercial Distribution

Package Type

box