Catalog Number

SYRI003314

Brand Name

Medline

Version/Model Number

SYRI003314

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151949,K151949,K151949

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

fa9a0eea-4707-4c84-a11d-e3fb26bfe498

Public Version Date

December 30, 2020

Public Version Number

1

DI Record Publish Date

December 22, 2020

Package DI Number

40888277327444

Quantity per Package

500

Contains DI Package

10193489008623

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE