TDR 3543C Detector 1067321

GUDID 60889971067326

TDR 3543C DETECTOR / FOR DIRECTVIEW SW

CARESTREAM HEALTH, INC.

Indirect flat panel x-ray detector

• Primary Device ID: 60889971067326
• NIH Device Record Key: a42271f4-f741-4b43-aac9-343e52ee87a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TDR 3543C Detector
• Version Model Number: TDR 3543C Detector
• Catalog Number: 1067321
• 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	60889971067326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090318

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: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-16

On-Brand Devices [TDR 3543C Detector]

• 60889974000184: AY-DETECTOR, COMPLETE, TDR3543C
• 60889971067326: TDR 3543C DETECTOR / FOR DIRECTVIEW SW