Catalog Number

-

Brand Name

Beesure

Version/Model Number

BE201

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

DYN

Product Code Name

Mouthpiece, Saliva Ejector

Public Device Record Key

f3af46fc-5ba3-4540-9077-85157338e7b7

Public Version Date

June 01, 2022

Public Version Number

1

DI Record Publish Date

May 24, 2022

Package DI Number

20817508021406

Quantity per Package

40

Contains DI Package

10817508021409

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case