Catalog Number

-

Brand Name

Andorate

Version/Model Number

GAR046

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

-

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

1fee3232-7ebe-43a8-a34a-8dafb15d2729

Public Version Date

September 03, 2019

Public Version Number

1

DI Record Publish Date

August 26, 2019

Package DI Number

26970661241587

Quantity per Package

4

Contains DI Package

16970661241580

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton