Catalog Number

-

Brand Name

SHINA

Version/Model Number

3258

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

K140949,K140949,K140949

Product Code

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

b9708bed-bd58-44b4-9978-17298f1681cf

Public Version Date

October 18, 2021

Public Version Number

2

DI Record Publish Date

March 31, 2021

Package DI Number

18800117132583

Quantity per Package

100

Contains DI Package

08800117132586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton