CS 1200 6560072

GUDID 60192156560070

CS1200 INTRA ORAL CAMERA AV

CARESTREAM DENTAL LLC

Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope Flexible video stomatoscope

• Primary Device ID: 60192156560070
• NIH Device Record Key: e58688f9-51cb-4ee8-931b-4f7448c01279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 1200
• Version Model Number: CS 1200
• Catalog Number: 6560072
• 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	60192156560070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112321

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 1200]

• 60192156560070: CS1200 INTRA ORAL CAMERA AV
• 60192156559999: CS1200 INTRA ORAL CAMERA WIRED USB
• 60192155950438: CS1200 Handpiece