NONE 8622359

GUDID 60889978622351

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

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 60889978622351
• NIH Device Record Key: fd57d943-4b27-48a2-91e3-944b4049eda4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NONE
• Version Model Number: NONE
• Catalog Number: 8622359
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889978622351 [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: 2020-12-22
• Device Publish Date: 2020-12-14

On-Brand Devices [NONE]

• 60889978622351: X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F
• 60889978621613: X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F