Catalog Number

-

Brand Name

Andorate

Version/Model Number

GAR044

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 11, 2019

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

MNK

Product Code Name

Endoscopic Bite Block

Public Device Record Key

91de32c5-87e3-4b39-bfcf-2de11d87abef

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

September 10, 2018

Package DI Number

16970934720071

Quantity per Package

100

Contains DI Package

06970934720074

Package Discontinue Date

May 11, 2019

Package Status

Not in Commercial Distribution

Package Type

Outer box