Catalog Number

116218ASTEK

Brand Name

Astek

Version/Model Number

116218ASTEK

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

-

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

64b91ff1-6579-4f70-9d1c-c0b11430f266

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

10843471150952

Quantity per Package

1

Contains DI Package

00843471150955

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package