Catalog Number

-

Brand Name

andorate® Biopsy Irrigator

Version/Model Number

GAR015

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

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

7ff665f8-f79c-475d-9139-07474f2e658a

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 28, 2022

Package DI Number

14897106953896

Quantity per Package

100

Contains DI Package

04897106953899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box