DTX Studio™ Core - DTX Studio Core 3.9 for Windows 64-bit - Nobel Biocare AB

Duns Number:353939929

Device Description: DTX Studio Core 3.9 for Windows 64-bit

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More Product Details

Catalog Number

300547

Brand Name

DTX Studio™ Core

Version/Model Number

3.9

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

3e9e0237-69c7-486d-ac98-0fa135381f14

Public Version Date

October 28, 2020

Public Version Number

1

DI Record Publish Date

October 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOBEL BIOCARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 782
2 A medical device with a moderate to high risk that requires special controls. 3680