Trophy 3D Imaging 5319553

GUDID 60192155319556

TROPHY 3D IMAGING

CARESTREAM DENTAL LLC

General-purpose dental x-ray system application software
Primary Device ID60192155319556
NIH Device Record Key6d0495b1-be10-499c-a1ea-bfaf47c0d6fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrophy 3D Imaging
Version Model NumberTrophy 3D Imaging
Catalog Number5319553
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160192155319556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-25
Device Publish Date2020-02-17

Devices Manufactured by CARESTREAM DENTAL LLC

60192155945076 - RIOSensor+2024-01-25 RIOSensor+ Size 1
60192155945083 - RIOSENSOR+2024-01-25 RIOSENSOR+ SIZE 2
60192155944864 - CS 8200 3D Access2023-12-20 CS 8200 3D ACCESS
60192155944833 - DENTRA III2023-06-12 DENTRA III SIZE 1
60192155944840 - DENTRA III2023-06-12 DENTRA III SIZE 2
60192155944543 - Swissmeda powered by Carestream Dental2022-10-31 Swissmeda powered by Carestream Dental
60192155943720 - CS 3800 Wired2022-02-21 CS 3800 3D I/O SCANNER WIRED
60192155944482 - CS Model+2021-11-15 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

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