Catalog Number

-

Brand Name

Beesure

Version/Model Number

BE715SSS

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

EBH

Product Code Name

Material, Impression Tray, Resin

Public Device Record Key

dc9dd3c4-cd70-4449-8006-e1c29380f736

Public Version Date

May 24, 2022

Public Version Number

3

DI Record Publish Date

December 28, 2021

Package DI Number

20817508021390

Quantity per Package

20

Contains DI Package

10817508021393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case