| Primary Device ID | 27290015107154 |
| NIH Device Record Key | 74d854b1-8ef5-487c-ac3c-886ba1801898 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comaneci 17 |
| Version Model Number | ANPP7199 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07290015107150 [Primary] |
| GS1 | 17290015107157 [Package] Contains: 07290015107150 Package: [3 Units] In Commercial Distribution |
| GS1 | 27290015107154 [Package] Contains: 17290015107157 Package: [4 Units] In Commercial Distribution |
| GS1 | 37290015107151 [Package] Contains: 07290015107150 Package: [2 Units] In Commercial Distribution |
| PUU | Temporary Coil Embolization Assist Device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-19 |
| Device Publish Date | 2019-05-17 |
| 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 | 2019-07-19 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 | 2019-07-19The 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. |
| 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 |