Catalog Number

-

Brand Name

andorate® Suction Channel Cleaning Adapter

Version/Model Number

GAR075

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

FFY

Product Code Name

Adaptor, Bulbs, Miscellaneous, For Endoscope

Public Device Record Key

4b06449a-1e2e-4557-87e6-f228885a44bc

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 08, 2021

Package DI Number

14897106953520

Quantity per Package

50

Contains DI Package

04897106953523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box