AccessGUDID - DEVICE: TRIOS 3 (05902768365474)

GUDID

Device Identifier (DI) Information

Brand Name: TRIOS 3
Version or Model: TRIOS 3 Pen grip scanner
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: 3shape Trios A/S

Primary DI Number: 05902768365474
Issuing Agency: GS1
Commercial Distribution End Date: July 17, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 305225025 *Terms of Use

Device Description: handheld 3D scanner with pen grip for intraoral scanning.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38597	Dental milling system, CAD/CAM, chairside	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 8000 and 11000 KiloPascal
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Atmospheric Pressure: between 8000 and 11000 KiloPascal
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c9d5c995-d6eb-4f22-abc5-d6a6449c9059
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: September 22, 2016