Catalog Number

-

Brand Name

Swissmeda Dental Planning System

Version/Model Number

2.14.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 18, 2018

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

-

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

07b9e8c7-131d-4a91-ab41-b19a14e3dd86

Public Version Date

August 09, 2018

Public Version Number

1

DI Record Publish Date

July 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-