DRX Plus 3543C Detector AC2603

GUDID 60889974000238

AY-PACKED-3543C DETECTOR-DRX PLUS

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector

• Primary Device ID: 60889974000238
• NIH Device Record Key: c2f3f109-2fe4-4fb2-811c-75c794d47da6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRX Plus 3543C Detector
• Version Model Number: DRX Plus 3543C Detector
• Catalog Number: AC2603
• 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	60889974000238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150766

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-16

On-Brand Devices [DRX Plus 3543C Detector]

• 60889974000238: AY-PACKED-3543C DETECTOR-DRX PLUS
• 60889975950549: PACKED, 3543C DETECTOR, DRX PLUS