CS 2200 5153580

GUDID 60192155153587

CS 2200 230V/170CM SHORT WALL MTD

CARESTREAM DENTAL LLC

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 60192155153587
• NIH Device Record Key: b4f2b2cd-1a22-4cfe-a67e-c563cb75f665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 2200
• Version Model Number: CS 2200
• Catalog Number: 5153580
• 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	60192155153587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060292

FDA Product Code

• EHD: UNIT, X-RAY, EXTRAORAL WITH TIMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-01-15

On-Brand Devices [CS 2200]

• 60192155153617: CS 2200 110V/170CM SHORT WALL MTD
• 60192155153600: CS 2200 110V/188CM STD WALL MTD
• 60192155153594: CS 2200 110V/205CM LONG WALL MTD
• 60192155153587: CS 2200 230V/170CM SHORT WALL MTD
• 60192155153570: CS 2200 230V/188CM STD WALL MTD
• 60192155153563: CS 2200 230V/205CM LONG WALL MTD