Medit Orthodontic Suite

GUDID 08800026700869

Medit Corp.

CAD/CAM software
Primary Device ID08800026700869
NIH Device Record Key11440f00-0e58-43ba-ab7e-c2a14e9a25a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedit Orthodontic Suite
Version Model Number2.0
Company DUNS688800085
Company NameMedit Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800026700869 [Primary]

FDA Product Code

PNNOrthodontic Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

Devices Manufactured by Medit Corp.

08800026700869 - Medit Orthodontic Suite2025-06-06
08800026700869 - Medit Orthodontic Suite2025-06-06
08800026700203 - Medit ClinicCAD2024-07-01 SW version: 0.9.x
08800026700289 - i9002024-04-17
08800026700296 - Handpiece Cover2024-04-17
08800026700302 - Reusable Tip (Medium)2024-04-17
08800026700319 - Reusable Tip (Large) 2024-04-17
08800026700326 - Calibration Tool 2024-04-17
08800026700340 - Desktop Cradle2024-04-17

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