Silent Scan

GUDID 00850010651088

Silent Scan 3200 console

AVOTEC, INC.

Patient audiovisual communication/entertainment system

• Primary Device ID: 00850010651088
• NIH Device Record Key: f61a0e85-a5b9-4ec3-a162-489b7f5d8ff7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silent Scan
• Version Model Number: 3200
• Company DUNS: 802279984
• Company Name: AVOTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: 7726920750
• Email: sales@avotecinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010651088 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2020-05-14
• Device Publish Date: 2020-05-06

On-Brand Devices [Silent Scan]

• 00850010651101: Complete Silent Scan 3200 system
• 00850010651095: Complete Silent Scan 3300 system.
• 00850010651088: Silent Scan 3200 console
• 00850010651071: Silent Scan 3300 console
• 00850010651040: Silent Scan Audio Transducer