Catalog Number

5914705

Brand Name

Sirona

Version/Model Number

20967

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

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

11b60700-ae30-4268-aa0f-04050a5428b4

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Package DI Number

10618125115256

Quantity per Package

5000

Contains DI Package

00618125115259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box