Catalog Number

-

Brand Name

Beesure

Version/Model Number

BE421

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

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

c83011a3-90a8-4b5f-94ad-6a918f489851

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Package DI Number

20817508021345

Quantity per Package

20

Contains DI Package

10817508021348

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case