Catalog Number

118202

Brand Name

Astek

Version/Model Number

118202

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"

-

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

EHY

Product Code Name

TRAY, IMPRESSION, PREFORMED

Public Device Record Key

16a9f0b7-fe48-46fe-80ff-a6f2a1bc7d59

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

25060111780702

Quantity per Package

20

Contains DI Package

15060111780705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case