Catalog Number

-

Brand Name

Polycarbonate syringes

Version/Model Number

5003-Y

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

K103736

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

c3ccd094-711e-489f-91d7-6f22ba300e1e

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

April 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-