- Physicians Office Resource

360 Nano Detachable Coil
TARGET - M0035442540

Device Description

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.

Environmental Conditions

Special Storage Condition, Specify

Store in cool, dry, dark place.

Device Sizes

Coil Length: 4.0 Centimeter

Secondary Coil Diameter: 2.5 Millimeter

Coil Length: 4.0 Centimeter
Secondary Coil Diameter: 2.5 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: HCG

Device Name: Device, Neurovascular Embolization

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 882.5950

Third Party Flag: N

Medical Specialty: NE

Code: KRD

Device Name: Device, Vascular, For Promoting Embolization

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 870.3300

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 07613252600305

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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