Catalog Number

-

Brand Name

Andorate® Bite Block 66 Fr with Oxygen Connection

Version/Model Number

GAR044

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 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"

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

ad2ad098-f599-4b9c-a4a0-a40fab5276a8

Public Version Date

January 10, 2022

Public Version Number

4

DI Record Publish Date

August 17, 2020

Package DI Number

14897106950567

Quantity per Package

100

Contains DI Package

04897106950560

Package Discontinue Date

April 06, 2021

Package Status

Not in Commercial Distribution

Package Type

Box