OnSight 3D Extremity System 1743574

GUDID 60889971743572

ONSIGHT 3D EXTREMITY SYS W RMT CONSOLE

CARESTREAM HEALTH, INC.

Limited-view-field CT system Limited-view-field CT system

• Primary Device ID: 60889971743572
• NIH Device Record Key: 5377ac9c-a766-4343-904f-4d7695e5b03e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OnSight 3D Extremity System
• Version Model Number: OnSight 3D Extremity System
• Catalog Number: 1743574
• 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	60889971743572 [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: 4
• Public Version Date: 2018-10-11
• Device Publish Date: 2017-01-20

On-Brand Devices [OnSight 3D Extremity System]

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