Catalog Number

SYRA101261

Brand Name

Medline

Version/Model Number

SYRA101261

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,K151991,K113091,K151991

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

67a70064-680d-49a2-aacf-b9d373376a97

Public Version Date

December 03, 2020

Public Version Number

1

DI Record Publish Date

November 25, 2020

Package DI Number

20888277654072

Quantity per Package

40

Contains DI Package

10888277654075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE