i-ED COIL 390-02H4

GUDID 04540778176546

The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.

KANEKA CORPORATION

Non-neurovascular embolization coil

• Primary Device ID: 04540778176546
• NIH Device Record Key: 423c97a2-8e84-4267-923a-eab71d4efef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-ED COIL
• Version Model Number: 390-02H4
• Catalog Number: 390-02H4
• Company DUNS: 690535406
• Company Name: KANEKA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
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• Phone: (800) 526-3522
• Email: xx@xx.xx
• Phone: (800) 526-3522
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Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540778176546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192068

FDA Product Code

• HCG: Device, Neurovascular Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-08
• Device Publish Date: 2020-06-30

On-Brand Devices [i-ED COIL]

• 04540778177796: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177772: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177734: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177710: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177659: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177635: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177628: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177321: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177314: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177284: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177260: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177246: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177239: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177222: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177208: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177185: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177154: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177123: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177093: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177079: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177055: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177048: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177017: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176997: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176980: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176591: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176584: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176577: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176553: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176546: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176539: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176522: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176515: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176508: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176478: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176461: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176447: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176430: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177611: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177604: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177550: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177543: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177253: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176423: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778176485: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778190429: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778190412: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177291: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the
• 04540778177031: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the