Catalog Number

-

Brand Name

Beesure

Version/Model Number

BE611OA

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

-

Product Code

EGS

Product Code Name

Handpiece, Contra- And Right-Angle Attachment, Dental

Public Device Record Key

513db2df-3489-41b1-a3bf-34ee2d59b214

Public Version Date

May 24, 2022

Public Version Number

3

DI Record Publish Date

December 27, 2021

Package DI Number

20817508022359

Quantity per Package

5

Contains DI Package

10817508022352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case