Catalog Number

ED052905IN

Brand Name

CARDINAL HEALTH

Version/Model Number

ED052905IN

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

K063755,K063755,K063755

Product Code

MEG

Product Code Name

SYRINGE, ANTISTICK

Public Device Record Key

de55f9b1-be14-43dd-9478-3922c14c39ab

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

55019517065563

Quantity per Package

6

Contains DI Package

35019517065569

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE