Catalog Number

-

Brand Name

Andorate Disposable Endoscope Bite Block (55.5 Fr)

Version/Model Number

GAR059

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

e93995a0-81e7-46d5-a0d0-c64f1f0242f4

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 24, 2018

Package DI Number

26970934720191

Quantity per Package

4

Contains DI Package

16970934720194

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton