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GUDID 00195411451142

Icon Knee Replacement Battery

COLLEGE PARK INDUSTRIES, INC.

Mechatronic external knee prosthesis

• Primary Device ID: 00195411451142
• NIH Device Record Key: 656cdf70-3dce-4502-a13a-0a770ff2f2a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icon
• Version Model Number: IC BATT
• Company DUNS: 623191137
• Company Name: COLLEGE PARK INDUSTRIES, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195411451142 [Primary]

FDA Product Code

• ISY: Joint, Knee, External Limb Component

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: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [Icon]

• 00195411451142: Icon Knee Replacement Battery
• 00195411451135: Icon Knee Pad Replacement Kit
• 00195411451128: Icon Knee Charging Kit, UK
• 00195411451111: Icon Knee Charging Kit, Euro
• 00195411451104: Icon Knee Charging Kit, US
• 00195411451098: Low Profile Threaded Connector, Ti
• 00195411451081: Icon Microprocessor Knee Assembly
• 00195411458905: Icon Knee Charging Blade Kit, Global