Catalog Number

-

Brand Name

andorate® 2-piece Cleaning Adapter Kit

Version/Model Number

GAR3875

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 24, 2021

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

439c38d0-83dd-450d-bc80-b14ad0203b72

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

March 12, 2021

Package DI Number

14897106951410

Quantity per Package

25

Contains DI Package

04897106951413

Package Discontinue Date

May 24, 2021

Package Status

Not in Commercial Distribution

Package Type

Box