DRX-Compass X-ray System 8624199

GUDID 60889978624195

X-RAY SYSTEM CONSOLE PDU 3 P 208-240 C/F

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 60889978624195
• NIH Device Record Key: 73b647cb-6090-4657-87d2-2e2717085555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRX-Compass X-ray System
• Version Model Number: DRX-Compass X-ray System
• Catalog Number: 8624199
• 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	60889978624195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201373

FDA Product Code

• KPR: System, x-ray, stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-19
• Device Publish Date: 2022-01-11

On-Brand Devices [DRX-Compass X-ray System]

• 60889978624744: X-RAY FMT SYSTEM ANALOG CONSOLE PDU C/F
• 60889978624737: X-RAY FMT SYSTEM DIGITAL CONSOLE PDU C/F
• 60889976704899: X-RAY FMT SYSTEM ANALOG CONSOLE PDU C/F
• 60889976704875: X-RAY FMT SYSTEM DIGITAL CONSOLE PDU C/F
• 60889978624195: X-RAY SYSTEM CONSOLE PDU 3 P 208-240 C/F
• 60889978624188: X-RAY SYSTEM CONSOLE PDU 3 P 380-480 C/F
• 60889978624768: XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD