Catalog Number

-

Brand Name

Jiyuan

Version/Model Number

JY-PK-350-18-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 01, 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

-

Product Code

HFB

Product Code Name

Forceps, Biopsy, Gynecological

Public Device Record Key

37a425d0-839b-4728-8622-d8dc88b0fc3f

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 10, 2022

Package DI Number

16973672290059

Quantity per Package

10

Contains DI Package

06973672290052

Package Discontinue Date

March 10, 2056

Package Status

In Commercial Distribution

Package Type

box