Catalog Number

1.013.2041

Brand Name

Packaged System, Kavo Nomad Pro2, GBL

Version/Model Number

1.013.2041

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

-

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

K173319

Product Code

EHD

Product Code Name

UNIT, X-RAY, EXTRAORAL WITH TIMER

Public Device Record Key

761398b7-7888-4a58-b51c-6d7272aa99c2

Public Version Date

March 02, 2020

Public Version Number

1

DI Record Publish Date

February 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-