CS 1200 9G5275

GUDID 60192155950438

CS1200 Handpiece

CARESTREAM DENTAL LLC

Flexible video stomatoscope

• Primary Device ID: 60192155950438
• NIH Device Record Key: 530a76e8-48fd-408d-b85c-7c8c58687a29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 1200
• Version Model Number: CS 1200
• Catalog Number: 9G5275
• 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	60192155950438 [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: 2
• Public Version Date: 2019-06-07
• 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