CS 8100 3D 5500319

GUDID 60192155500312

CS 8100 3D

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: 60192155500312
• NIH Device Record Key: 0e76349e-75c6-4487-976b-b68ee26fbaad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS 8100 3D
• Version Model Number: CS 8100 3D
• Catalog Number: 5500319
• 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	60192155500312 [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: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-01-15

On-Brand Devices [CS 8100 3D]

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