Catalog Number

-

Brand Name

Jelco

Version/Model Number

412510

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

K061194,K061194,K061194

Product Code

MEG

Product Code Name

SYRINGE, ANTISTICK

Public Device Record Key

abf44ca9-9ca7-483a-bc8c-9cc6e51b9510

Public Version Date

September 16, 2021

Public Version Number

1

DI Record Publish Date

September 08, 2021

Package DI Number

30351688075479

Quantity per Package

400

Contains DI Package

10351688075475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case