OTOPLAN 20072

GUDID 07640167222414

CAScination AG

Radiology picture archiving and communication system workstation

• Primary Device ID: 07640167222414
• NIH Device Record Key: 302d27f7-5368-4eff-b294-283f20a991d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOPLAN
• Version Model Number: 2.0
• Catalog Number: 20072
• Company DUNS: 485258433
• Company Name: CAScination AG
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167222414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220300

FDA Product Code

• QQE: Image Management Software For Planning Of Otologic And Neurotologic Procedures

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: 2022-07-19
• Device Publish Date: 2022-07-11

On-Brand Devices [OTOPLAN]

• 07640167220724: 1.3
• 07640167222414: 2.0