Catalog Number

-

Brand Name

Andorate®

Version/Model Number

GAR023

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYZ

Product Code Name

Trap, Sterile Specimen

Public Device Record Key

aeffac67-ab44-4e4d-9323-49d53e3ce040

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

October 30, 2018

Package DI Number

16970661241498

Quantity per Package

12

Contains DI Package

06970661241491

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box