CS 7600 1018902

GUDID 60192151018903

CS 7600 SMART PLATE STARTER KIT

CARESTREAM DENTAL LLC

Dental computed radiography digital imaging scanner Dental computed radiography digital imaging scanner

• Primary Device ID: 60192151018903
• NIH Device Record Key: b9dbaedd-ad22-4562-a05d-d916167b6c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 7600
• Version Model Number: CS 7600
• Catalog Number: 1018902
• 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	40192151018909 [Primary]
GS1	60192151018903 [Package]; Contains: 40192151018909; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111649

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-03-01

On-Brand Devices [CS 7600]

• 60192151068403: CS7600 Imaging System for US, CA, Brazil
• 60192151014318: CS 7600 SCAN&GO DEVICE
• 60192151014301: CS 7600 INTRAORAL IMAGING PLATE SYS
• 60192151018903: CS 7600 SMART PLATE STARTER KIT
• 60192155942730: CS 7600 IMAGING PLATE SYSTEM