Primary Device ID | 00763000354466 |
NIH Device Record Key | 002038bf-d386-4268-85de-9e6ce3a12fb5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Symplicity Spyral™ |
Version Model Number | RDN016 |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Storage Environment Temperature | Between -35 Degrees Celsius and 57 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 30 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Store product in cool, dry place. Do not expose to organic solvents, ionizing radiation or ultraviolet light. |
Storage Environment Atmospheric Pressure | Between 595 millibar and 1060 millibar |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000354466 [Primary] |
QYI | Ablation catheter, renal denervation |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-08 |
Device Publish Date | 2023-11-30 |
20763000651736 - Aortic Punch | 2025-03-31 Aortic Punch APU425 - 2.5mm punch size |
20763000651743 - Aortic Punch | 2025-03-31 Aortic Punch APU430 - 3.0mm punch size |
20763000651750 - Aortic Punch | 2025-03-31 Aortic Punch APU435 - 3.5mm punch size |
20763000651767 - Aortic Punch | 2025-03-31 Aortic Punch APU440 - 4.0mm punch size |
20763000651774 - Aortic Punch | 2025-03-31 Aortic Punch APU444 - 4.4mm punch size |
20763000651781 - Aortic Punch | 2025-03-31 Aortic Punch APU448 - 4.8mm punch size |
20763000651798 - Aortic Punch | 2025-03-31 Aortic Punch APU450 - 5.0mm punch size |
20763000651804 - Aortic Punch | 2025-03-31 Aortic Punch APU452 - 5.2mm punch size |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SYMPLICITY SPYRAL 97652566 not registered Live/Pending |
Medtronic Ireland Manufacturing Unlimited Company 2022-10-28 |
![]() SYMPLICITY SPYRAL 97119448 not registered Live/Pending |
Medtronic, Inc. 2021-11-11 |
![]() SYMPLICITY SPYRAL 87541444 not registered Live/Pending |
Medtronic Ardian Luxembourg S.a.r.l. 2017-07-25 |
![]() SYMPLICITY SPYRAL 85928930 not registered Dead/Abandoned |
Medtronic Ardian Luxembourg S.a.r.l. 2013-05-10 |
![]() SYMPLICITY SPYRAL 85797529 5022773 Live/Registered |
Medtronic Ardian Luxembourg S.a.r.l. 2012-12-07 |