Catalog Number

-

Brand Name

andorate® Bite Block 55.5Fr with Strap

Version/Model Number

SDPC0209A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 14, 2020

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

d07315e5-e8a0-4eb5-9ccc-867005f78ff9

Public Version Date

March 02, 2022

Public Version Number

3

DI Record Publish Date

August 17, 2020

Package DI Number

14897106952424

Quantity per Package

100

Contains DI Package

04897106952427

Package Discontinue Date

December 14, 2020

Package Status

Not in Commercial Distribution

Package Type

Box