Catalog Number

-

Brand Name

Sterile Single-use Syringe with Needle

Version/Model Number

5mL LS

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

K163161,K163161,K163161

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

159e1486-0a6e-4123-a00e-aa1c8bb19067

Public Version Date

April 06, 2021

Public Version Number

1

DI Record Publish Date

March 29, 2021

Package DI Number

16920756728472

Quantity per Package

100

Contains DI Package

06920756728475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-