CardioMD 9PMS3060

GUDID 05711665002012

Gamma Camera System

Ddd-Diagnostic A/S

Stationary gamma camera system

• Primary Device ID: 05711665002012
• NIH Device Record Key: 4b283b3a-ca80-481f-8fe8-11c043f0fd04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioMD
• Version Model Number: CorCam Gamma Camera System
• Catalog Number: 9PMS3060
• Company DUNS: 305116642
• Company Name: Ddd-Diagnostic A/S
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: support@ddd-diagnostic.dk

Device Dimensions

• Width: 284 Centimeter
• Depth: 150 Centimeter
• Height: 150 Centimeter
• Weight: 815 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711665002012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011611

FDA Product Code

• KPS: System, Tomography, Computed, Emission

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: 2018-08-06
• Device Publish Date: 2018-07-04

On-Brand Devices [CardioMD]

• 05711665002012: Gamma Camera System
• 05711665002006: Gamma Camera System