| Primary Device ID | 07290017590325 |
| NIH Device Record Key | e165eeed-5a0f-4edb-878b-79803da5cc5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Auryon Atherectomy Catheter |
| Version Model Number | EXM-4012-H000 |
| Catalog Number | EXM-4012-H000 |
| Company DUNS | 600468941 |
| Company Name | EXIMO 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 | true |
| 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 |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Outer Diameter | 1.7 Millimeter |
| Length | 150 Centimeter |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017590325 [Primary] |
| MCW | Catheter, Peripheral, Atherectomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-24 |
| Device Publish Date | 2024-09-16 |
| 07290017590172 | Catheter Eximo Atherectomy 2.35mm - Hydrophilic Coated |
| 07290017590165 | Catheter Eximo Atherectomy 2mm - Hydrophilic Coated |
| 07290017590158 | Catheter Eximo Atherectomy 0.9mm - Hydrophilic Coated |
| 07290017590141 | Catheter Eximo Atherectomy 1.5mm - Hydrophilic Coated |
| 07290017590318 | Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW |
| 07290017590301 | Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW |
| 07290017590295 | Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating |
| 07290017590288 | Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW - Hydrophilic Coating |
| 07290017590332 | Auryon Atherectomy Catheter 1.7mm OTW |
| 07290017590325 | Auryon Atherectomy Catheter 1.7mm - Hydrophilic Coated |