Swissmeda Dental Planning System - Swissmeda AG

Duns Number:485199660

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More Product Details

Catalog Number

-

Brand Name

Swissmeda Dental Planning System

Version/Model Number

2.14

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 06, 2018

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

7c30610e-aa23-49a9-ae99-a475ffeb20c5

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SWISSMEDA AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13