i-ED COIL

Basic Information

• Brand Name: i-ED COIL
• Primary DI: 04540778176546
• Version / Model: 390-02H4
• Catalog Number: 390-02H4
• Company Name: KANEKA CORPORATION
• Labeler DUNS: 690535406
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-30
• Public Version: 4
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 423c97a2-8e84-4267-923a-eab71d4efef4

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCG	Device, Neurovascular Embolization	Neurology	882.5950	2
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	870.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60941	Non-neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.	Yes	Active
60940	Neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04540778176546	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Complex (Silky Soft) 10inch 2.5mm x 4cm
Device Size Text, specify			Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter

Storage Conditions

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