CoreLite

GUDID 05060508820017

X-ray specimen cabinet

CIRDAN IMAGING LIMITED

Specimen x-ray system IVD

• Primary Device ID: 05060508820017
• NIH Device Record Key: fae361ac-874a-4d6e-a00e-dd1ddaf69cf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreLite
• Version Model Number: 1
• Company DUNS: 216744109
• Company Name: CIRDAN IMAGING LIMITED
• 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: +442892660880
• Email: jmcgarry@cirdan.com
• Phone: +442892660880
• Email: jmcgarry@cirdan.com
• Phone: +442892660880
• Email: jmcgarry@cirdan.com
• Phone: +442892660880
• Email: jmcgarry@cirdan.com
• Phone: +442892660880
• Email: jmcgarry@cirdan.com
• Phone: +442892660880
• Email: jmcgarry@cirdan.com
• Phone: +442892660880
• Email: jmcgarry@cirdan.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060508820017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193317

FDA Product Code

• MWP: Cabinet, X-Ray System

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: 2020-04-08
• Device Publish Date: 2020-03-31

Devices Manufactured by CIRDAN IMAGING LIMITED

• 05060508820017 - CoreLite: 2020-04-08X-ray specimen cabinet
• 05060508820017 - CoreLite: 2020-04-08 X-ray specimen cabinet
• 05060508820000 - Pathnet Blood Bank Transfusion (L-2300): 2019-09-27