CS 8100 3D 5942123

GUDID 60192155942129

CS 8100 3D Select

CARESTREAM DENTAL LLC

Cone beam computed tomography system, head/neck

• Primary Device ID: 60192155942129
• NIH Device Record Key: 62b1104b-c95d-441d-a339-be85ffda534d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 8100 3D
• Version Model Number: CS 8100 3D
• Catalog Number: 5942123
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155942129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133406

FDA Product Code

• OAS: X-Ray, Tomography, Computed, 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: 2019-10-28
• Device Publish Date: 2019-05-10

On-Brand Devices [CS 8100 3D]

• 60192155500312: CS 8100 3D
• 60192155942129: CS 8100 3D Select