Catalog Number

SYR110522

Brand Name

Medline

Version/Model Number

SYR110522

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

78deb472-58a9-402c-b0d8-4a2f1e577f0c

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 19, 2021

Package DI Number

20193489029052

Quantity per Package

100

Contains DI Package

10193489029055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX