Catalog Number

-

Brand Name

Andorate

Version/Model Number

GAR018-S

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

ODC

Product Code Name

Endoscope Channel Accessory

Public Device Record Key

43d6771e-0c2f-4a13-83cd-92b94fec5c8d

Public Version Date

September 03, 2019

Public Version Number

1

DI Record Publish Date

August 26, 2019

Package DI Number

26970661241532

Quantity per Package

10

Contains DI Package

16970661241535

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton