DigniCool REF 11010

GUDID 07350002100097

Dignitana AB

Scalp cooling system

• Primary Device ID: 07350002100097
• NIH Device Record Key: d1d73955-fc5f-4385-a133-6d4c7414eadf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigniCool
• Version Model Number: 0.5L
• Catalog Number: REF 11010
• Company DUNS: 775901619
• Company Name: Dignitana AB
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com
• Phone: 4646163090
• Email: info@dignitana.com

Device Dimensions

• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter
• Total Volume: 0.5 Liter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002100097 [Primary]

FDA Product Code

• PMC: Scalp Cooling System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-01

On-Brand Devices [DigniCool]

• 07350002100097: 0.5L
• 07350002100080: 5L