Axxent Surface Controller XP1200

GUDID 00858012005526

Axxent Surface Controller

Icad, Inc.

General-purpose brachytherapy system applicator, manual

• Primary Device ID: 00858012005526
• NIH Device Record Key: 770607f8-72fe-44b9-8714-c6e9c0baab9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axxent Surface Controller
• Version Model Number: 750850
• Catalog Number: XP1200
• Company DUNS: 108870254
• Company Name: Icad, Inc.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153570

FDA Product Code

• JAD: System, Therapeutic, X-Ray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-20

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