CS 9300 Select 5319710

GUDID 60192155319716

CS 9300 SELECT 230V

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck

• Primary Device ID: 60192155319716
• NIH Device Record Key: b07045b7-0c83-484d-a6e9-425e07e219d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 9300 Select
• Version Model Number: CS 9300 Select
• Catalog Number: 5319710
• 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	60192155319716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103659

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: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-28
• Device Publish Date: 2018-01-15

On-Brand Devices [CS 9300 Select]

• 60192155319747: CS 9300 SELECT 110V
• 60192155319716: CS 9300 SELECT 230V