Catalog Number

BT50

Brand Name

BluTab 750mL Tablets

Version/Model Number

BT50

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

0f6be54c-56c4-4713-82d9-19fd0949f16e

Public Version Date

April 28, 2020

Public Version Number

1

DI Record Publish Date

April 20, 2020

Package DI Number

00850018182058

Quantity per Package

12

Contains DI Package

00850018182010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-