Catalog Number

SYR110215

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

SYR110215

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

f6371137-2f3c-4f5d-a0d3-e1114edcde32

Public Version Date

April 02, 2021

Public Version Number

1

DI Record Publish Date

March 25, 2021

Package DI Number

40080196449638

Quantity per Package

400

Contains DI Package

30080196449631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE