OnSight 3D Extremity System 1743566

GUDID 60889971743565

ONSIGHT 3D EXTREMITY SYS W ATCH CONSOLE

CARESTREAM HEALTH, INC.

Limited-view-field CT system

• Primary Device ID: 60889971743565
• NIH Device Record Key: 39f7f276-e52e-40fe-b2ad-34d5c92e97af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnSight 3D Extremity System
• Version Model Number: OnSight 3D Extremity System
• Catalog Number: 1743566
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, INC.
• 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	60889971743565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160723

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2018-07-06
• Device Publish Date: 2017-01-19

On-Brand Devices [OnSight 3D Extremity System]

• 60889971743572: ONSIGHT 3D EXTREMITY SYS W RMT CONSOLE
• 60889971743565: ONSIGHT 3D EXTREMITY SYS W ATCH CONSOLE