CS 8100SC 3D 5500111

GUDID 60192155500114

CS 8100SC 3D

CARESTREAM DENTAL LLC

Stationary cephalometric x-ray system, digital Stationary cephalometric x-ray system, digital

• Primary Device ID: 60192155500114
• NIH Device Record Key: f381947a-753e-4a30-b192-0e6883760177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 8100SC 3D
• Version Model Number: CS 8100SC 3D
• Catalog Number: 5500111
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155500114 [Primary]

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: 5
• Public Version Date: 2019-10-28
• Device Publish Date: 2018-01-15

On-Brand Devices [CS 8100SC 3D]

• 60192155500114: CS 8100SC 3D
• 60192155942136: CS 8100SC 3D Select