Catalog Number

SNL12510

Brand Name

CAINA

Version/Model Number

1ML LL 25GX1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113091,K113091,K113091

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

63b3d6a1-4d2c-4915-86f4-536751e81402

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 10, 2021

Package DI Number

16971564465387

Quantity per Package

100

Contains DI Package

06971564465380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-