Catalog Number

-

Brand Name

SHINA

Version/Model Number

0223

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062702,K062702

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

39a819dd-b5bb-4be6-a80c-e501ad7521a1

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Package DI Number

18800117102234

Quantity per Package

100

Contains DI Package

08800117102237

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton