Catalog Number

BRAD616

Brand Name

Alpine Dental

Version/Model Number

AD616

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

ELW

Product Code Name

Material, Impression

Public Device Record Key

8d715309-b01f-49bb-9f07-0d4be8dc9dcd

Public Version Date

December 20, 2019

Public Version Number

1

DI Record Publish Date

December 12, 2019

Package DI Number

D922BRAD6151

Quantity per Package

100

Contains DI Package

D922BRAD6160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box