Catalog Number

-

Brand Name

Jiyuan

Version/Model Number

JY-DEH-002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 18, 2056

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K210270

Product Code

HIH

Product Code Name

Hysteroscope (And Accessories)

Public Device Record Key

4a29c61d-5a41-407f-b077-4ea6f640acb9

Public Version Date

June 16, 2022

Public Version Number

3

DI Record Publish Date

February 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-