4343R Digital Image Receptor 8607582

GUDID 60889978607587

GOS Scintillator 4343 CM

CARESTREAM HEALTH, INC.

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

• Primary Device ID: 60889978607587
• NIH Device Record Key: 6eabefc0-c52a-478a-8712-d7b3dd5c5221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4343R Digital Image Receptor
• Version Model Number: 4343R Digital Image Receptor
• Catalog Number: 8607582
• 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	60889978607587 [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: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-12-15

On-Brand Devices [4343R Digital Image Receptor]

• 60889978607587: GOS Scintillator 4343 CM
• 60889974007473: 43X43 GOS DETECTOR
• 60889974007466: DRX-DETECTOR 43X43 CSI FIXED
• 60889974000375: AY-DETECTOR, TESTED, 43 X 43