Catalog Number

SRI-0202027

Brand Name

OnX - A1

Version/Model Number

SRI-0202027

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ELJ

Product Code Name

Teeth, Artificial, Posterior With Metal Insert

Public Device Record Key

8d2b56f3-96ed-46c8-af23-84ba3bbb898a

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

Package DI Number

10850039704083

Quantity per Package

1

Contains DI Package

00850039704086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box