SCAN CEPH 5942396

GUDID 60192155942396

SCAN CEPH FOR CS 9600

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck

• Primary Device ID: 60192155942396
• NIH Device Record Key: b490fddd-55b9-458b-893a-b9ab1eaa7be6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCAN CEPH
• Version Model Number: SCAN CEPH
• Catalog Number: 5942396
• 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: false
• Serial Number: true
• 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	60192155942396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181136

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2020-02-25
• Device Publish Date: 2020-02-17

On-Brand Devices [SCAN CEPH]

• 60192155500435: SCAN CEPH UPGRADE FOR CS 8100 3D
• 60192155942396: SCAN CEPH FOR CS 9600
• 60192155943232: SCAN CEPH FOR CS 8200 3D