CS Model+ 5942719

GUDID 60192155942716

CS MODEL+

CARESTREAM DENTAL LLC

CAD/CAM software

• Primary Device ID: 60192155942716
• NIH Device Record Key: 226df3ec-4e3f-4468-b1c0-b68b126e5eaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS Model+
• Version Model Number: CS Model+
• Catalog Number: 5942719
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155942716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193390

FDA Product Code

• PNN: Orthodontic Software

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-05
• Device Publish Date: 2020-04-27

On-Brand Devices [CS Model+]

• 60192155942716: CS MODEL+
• 60192155944482: LICENCE CS MODEL+ V5 ALIGNER CAPABILITY