CARESTREAM DRX-EVOLUTION Plus 8624256

GUDID 60889978624256

DRX-EVOLUTION PLUS SYSTEM L1741040

CARESTREAM HEALTH, INC.

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 60889978624256
• NIH Device Record Key: ab8417b2-e166-4bbd-a00e-b300c7114da8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARESTREAM DRX-EVOLUTION Plus
• Version Model Number: CARESTREAM DRX-EVOLUTION Plus
• Catalog Number: 8624256
• 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	60889978624256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091889

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: 2021-05-24
• Device Publish Date: 2021-05-16

On-Brand Devices [CARESTREAM DRX-EVOLUTION Plus]

• 60889978624263: DRX-EVOLUTION PLUS SYSTEM LOSHPD
• 60889978624256: DRX-EVOLUTION PLUS SYSTEM L1741040
• 60889978624249: DRX-EVOLUTION PLUS SYSTEM L1741032
• 60889978624218: DRX-EVOLUTION PLUS SYSTEM L1739218
• 60889978624201: DRX-EVOLUTION PLUS SYSTEM L1739192