Catalog Number

6409952

Brand Name

Sirona

Version/Model Number

6409952

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)

Yes

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

198b34d4-22a8-4807-9dde-fae5b53c4916

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

10618125155931

Quantity per Package

300

Contains DI Package

00618125155934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box