Catalog Number

116430

Brand Name

Astek

Version/Model Number

116430

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ECB

Product Code Name

UNIT, SYRINGE, AIR AND/OR WATER

Public Device Record Key

537a7416-2aa8-4198-b1cb-5c5fd9691be4

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

10843471151591

Quantity per Package

250

Contains DI Package

00843471151594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package