Codonics Horizon® Multi-media Imager

GUDID 00814905020182

Grayscale/Color Desktop Large Format Film and Paper Diagnostic Imager -53C

CODONICS INC.

Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera Diagnostic-imaging multiformat camera

• Primary Device ID: 00814905020182
• NIH Device Record Key: 6199f5b8-97f3-42eb-8e38-3cea6b8d530d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Codonics Horizon® Multi-media Imager
• Version Model Number: 53C
• Company DUNS: 101533727
• Company Name: CODONICS 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: true
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com
• Phone: 4402431334
• Email: support@codonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814905020182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021054

FDA Product Code

• LMC: Camera, Multi Format, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [Codonics Horizon® Multi-media Imager]

• 00814905020212: Grayscale Desktop Large Format Film and Paper Diagnostic Imager - 150C
• 00814905020205: Grayscale Desktop Large Format Film and Paper Diagnostic Imager - 55C
• 00814905020199: Grayscale/Color Desktop Small Format Film and Paper Diagnostic Imager - 54C
• 00814905020182: Grayscale/Color Desktop Large Format Film and Paper Diagnostic Imager -53C
• 00814905020175: Grayscale Desktop Large Format Film and Paper Diagnostic Imager - 52C
• 00814905020168: Grayscale/Color Desktop Small Format Film and Paper Diagnostic Imager - 51C
• 00814905020151: Grayscale/Color Desktop Large Format Film and Paper Diagnostic Imager - 50C