Comaneci

GUDID 07290015107136

The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath.

RAPID MEDICAL LTD

Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent Bare-metal intracranial vascular stent

• Primary Device ID: 07290015107136
• NIH Device Record Key: a38456ef-861a-40cc-9136-a4860b5fc302
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comaneci
• Version Model Number: ANPP7177
• Company DUNS: 532702946
• Company Name: RAPID MEDICAL LTD
• 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	07290015107136 [Primary]
GS1	17290015107133 [Package]; Package: [3 Units]; In Commercial Distribution
GS1	27290015107130 [Package]; Contains: 17290015107133; Package: [4 Units]; In Commercial Distribution
GS1	37290015107137 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170064

FDA Product Code

• PUU: Temporary Coil Embolization Assist Device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-19
• Device Publish Date: 2019-05-17

Devices Manufactured by RAPID MEDICAL LTD

• 17290015107300 - Tigertriever 13 Revascularization Device: 2022-08-05 The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, niti
• 07290015107235 - Drivewire LR: 2021-09-03 The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire
• 07290015107242 - Drivewire SR: 2021-09-03 The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire
• 07290015107266 - Tigertriever Revascularization Device: 2021-04-13 The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol
• 07290015107273 - Tigertriever 17 Revascularization Device: 2021-04-13 The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol
• 07290015107136 - Comaneci: 2019-07-19The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath.
• 07290015107136 - Comaneci: 2019-07-19 The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysm
• 07290015107143 - Comaneci Petit: 2019-07-19 The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysm
• 27290015107154 - Comaneci 17: 2019-07-19 The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysm