Catalog Number

-

Brand Name

Andorate®

Version/Model Number

GAR004

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

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Public Device Record Key

2844a4e8-efa1-4133-9335-99d46288e2ec

Public Version Date

October 02, 2019

Public Version Number

2

DI Record Publish Date

October 02, 2018

Package DI Number

16970661240330

Quantity per Package

50

Contains DI Package

06970661240333

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box