StrataVarius
GUDID 00763000292553
TOOL 45809 STRATAVARIUS ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer Cerebrospinal fluid shunt valve programmer| Primary Device ID | 00763000292553 |
| NIH Device Record Key | f31a71b5-7de9-4e57-81b3-4a80bb5096bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StrataVarius |
| Version Model Number | 45809 |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000292553 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041992
FDA Product Code
| JXG | Shunt, central nervous system and components |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-25 |
On-Brand Devices [StrataVarius]
| 00763000266981 | TOOL 45809 STRATAVARIUS ADJUSTMENT |
| 00763000266974 | KIT 45806 STRATA VARIUS |
| 00763000292553 | TOOL 45809 STRATAVARIUS ADJUSTMENT |
Trademark Results [StrataVarius]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRATAVARIUS 77046654 3248876 Live/Registered |
Medtronic, Inc. 2006-11-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.