FusionCoil™

GUDID 00853730006220

Implanted Marker in Needle

CORTEX MANUFACTURING INC.

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• Primary Device ID: 00853730006220
• NIH Device Record Key: daba2408-4699-4df0-999a-c530e15a780c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FusionCoil™
• Version Model Number: FC-1.0-5-18-5
• Company DUNS: 832596816
• Company Name: CORTEX MANUFACTURING 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853730006220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102506

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-24

On-Brand Devices [FusionCoil™]

• 00853730006268: Implanted Marker in Needle
• 00853730006251: Implanted Marker in Needle
• 00853730006244: Implanted Marker in Needle
• 00853730006237: Implanted Marker in Needle
• 00853730006220: Implanted Marker in Needle
• 00853730006213: Implanted Marker in Needle
• 00853730006206: Implanted Marker in Needle