CS 1500 6559850

GUDID 60192156559852

CS1500 HAND PIECE WIRELESS

CARESTREAM DENTAL LLC

Flexible video stomatoscope

• Primary Device ID: 60192156559852
• NIH Device Record Key: 13a8035d-0996-4c41-8a67-9043c7bd2529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 1500
• Version Model Number: CS 1500
• Catalog Number: 6559850
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192156559852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091186

FDA Product Code

• EIA: Unit, Operative 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: 3
• Public Version Date: 2020-02-10
• Device Publish Date: 2019-03-01

On-Brand Devices [CS 1500]

• 60192156559852: CS1500 HAND PIECE WIRELESS
• 60192156559814: CS1500 INTRA ORAL CAMERA WIRED USB
• 60192156559807: CS1500 INTRA ORAL CAMERA WIRELESS