Catalog Number

-

Brand Name

andorate® Bite Block 66Fr with Strap

Version/Model Number

SDPC0210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 20, 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"

-

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

c4980e9a-82a4-45c3-b795-da1407e91206

Public Version Date

March 02, 2022

Public Version Number

3

DI Record Publish Date

August 10, 2020

Package DI Number

14897106952431

Quantity per Package

100

Contains DI Package

04897106952434

Package Discontinue Date

November 20, 2020

Package Status

Not in Commercial Distribution

Package Type

Box