DRX-Evolution Plus System 1739465

GUDID 60889971739469

DRX-Evolution Plus Transbay OTC System

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 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: 60889971739469
• NIH Device Record Key: af59c462-4fd5-4893-bc44-8271fc299e54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRX-Evolution Plus System
• Version Model Number: DRX-Evolution Plus System
• Catalog Number: 1739465
• 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	60889971739469 [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: 2021-07-21
• Device Publish Date: 2021-07-13

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• 60889971739230: Elevating Table - DRX Evo Plus
• 60889971739193: DRX-Evolution Plus Automatic - Dual Buck
• 60889971035141: DRX-EVO MOTOR CSH WS ONLY/X-PCSH4343-X-X
• 60889971026170: DRX-EVOLUTN PREMIUM CSH WS W/ SLIM E-BOX
• 60889971016140: DRX EVO FIXD ELE TBL MDL VX3733-TAB
• 60889971741035: DRX-Evolution Plus System (B-PCSH-P-X)
• 60889971739469: DRX-Evolution Plus Transbay OTC System
• 60889971739223: DRX-Evolution Plus System (P-X-P-X)
• 60889971739216: DRX-Evolution Plus System (P-PCSCH-X-X)