Catalog Number

-

Brand Name

andorate® Bite Block 55.5Fr with Strap and Tooth Protector

Version/Model Number

SDPC0209

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

MNK

Product Code Name

Endoscopic Bite Block

Public Device Record Key

ed81d76e-35be-468d-a972-d3b56793dba4

Public Version Date

January 10, 2022

Public Version Number

2

DI Record Publish Date

March 12, 2021

Package DI Number

14897106953575

Quantity per Package

100

Contains DI Package

04897106953578

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box