Catalog Number

BE-002S

Brand Name

Plasdent

Version/Model Number

BE-002S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EGZ

Product Code Name

Holder, Film, X-Ray

Public Device Record Key

87122e59-0ae6-4a4c-9a68-97a60c374486

Public Version Date

March 30, 2022

Public Version Number

1

DI Record Publish Date

March 22, 2022

Package DI Number

D832BE002S2

Quantity per Package

100

Contains DI Package

D832BE002S1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case