Catalog Number

GIS-1S

Brand Name

BlueBloc Endoscopy Bite Block

Version/Model Number

GIS-1

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K931044,K931044,K931044

Product Code

MNK

Product Code Name

Endoscopic Bite Block

Public Device Record Key

620e8db4-a1c1-402f-81f0-87083342225a

Public Version Date

July 14, 2021

Public Version Number

1

DI Record Publish Date

July 06, 2021

Package DI Number

10893029002523

Quantity per Package

100

Contains DI Package

00893029002526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master