Catalog Number

901084

Brand Name

Ceph upgrade kit for OP 3D

Version/Model Number

Ceph upgrade kit for OP 3D

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

-

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

K180947

Product Code

OAS

Product Code Name

X-Ray, Tomography, Computed, Dental

Public Device Record Key

2ed19764-e5ef-41d5-962f-264b550d3f01

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-