Tech In Motion - The medical device Tech in Motion® includes the - MODJAW

Duns Number:265572589

Device Description: The medical device Tech in Motion® includes the following parts:• A camera to detect track The medical device Tech in Motion® includes the following parts:• A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion.• A set of trackers intended to be placed on the patient’s head and in patient’s mouth.• A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in left-handed configurations.

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More Product Details

Catalog Number

TIM Left-handed US

Brand Name

Tech In Motion

Version/Model Number

TIML

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

NFS

Product Code Name

Device, Jaw Tracking, For Monitoring Jaw Positions

Device Record Status

Public Device Record Key

7e742297-7b7d-441b-8dd6-c76e8ca88f53

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MODJAW" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9