PowerLook PRO+ 4GPU Tower Platform, OUS

GUDID 00850008977299

Icad, Inc.

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• Primary Device ID: 00850008977299
• NIH Device Record Key: f3c9be04-5467-4ee0-80c3-322865b07043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerLook PRO+ 4GPU Tower Platform, OUS
• Version Model Number: DSC018-08
• Company DUNS: 108870254
• Company Name: Icad, Inc.
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008977299 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

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: 2024-06-18
• Device Publish Date: 2024-06-10

On-Brand Devices [PowerLook PRO+ 4GPU Tower Platform, OUS]

• 00850008977428: DSC032-01, DSC032-02, DSC032-03
• 00850008977299: DSC018-08