Catalog Number

-

Brand Name

Jelco

Version/Model Number

4427-TB

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

K063755,K063755,K063755

Product Code

MEG

Product Code Name

SYRINGE, ANTISTICK

Public Device Record Key

c8a78e0a-25ec-4b38-8b7e-7f5394db8d74

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 17, 2017

Package DI Number

10351688064486

Quantity per Package

100

Contains DI Package

00351688064489

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX