CS 8100 5303045

GUDID 60192155303043

CS 8100 110V 230V

CARESTREAM DENTAL LLC

Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital Stationary extraoral dental x-ray system, digital

• Primary Device ID: 60192155303043
• NIH Device Record Key: a8437437-a88b-46d0-8a4a-434d9801b6c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 8100
• Version Model Number: CS 8100
• Catalog Number: 5303045
• 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	60192155303043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120975

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2018-10-24

On-Brand Devices [CS 8100]

• 60192155311321: CS 8100
• 60192155303067: CS 8100 ACCESS 110V 230V
• 60192155303043: CS 8100 110V 230V