Logicon Caries Detector 5942750

GUDID 60192155942754

CSD LOGICON CARIES DETECTOR

CARESTREAM DENTAL LLC

General-purpose dental x-ray system application software

• Primary Device ID: 60192155942754
• NIH Device Record Key: 12882853-cff5-4ba8-b612-56fab343f07a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logicon Caries Detector
• Version Model Number: Logicon Caries Detector
• Catalog Number: 5942750
• Company DUNS: 019796106
• Company Name: CARESTREAM DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155942754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980025

FDA Product Code

• MYN: Analyzer, Medical Image

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-20
• Device Publish Date: 2019-12-01

On-Brand Devices [Logicon Caries Detector]

• 60192156851628: LOGICON SITE LIC (UP TO 10) W/IWT
• 60192155942754: CSD LOGICON CARIES DETECTOR