Liberta RC™ 62400
GUDID 05415067047663
Implantable Pulse Generator
ADVANCED NEUROMODULATION SYSTEMS, INC.
Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system Deep brain electrical stimulation system| Primary Device ID | 05415067047663 |
| NIH Device Record Key | cfa5691e-574b-4c6d-aaf9-bddf53d1de56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Liberta RC™ |
| Version Model Number | 62400 |
| Catalog Number | 62400 |
| Company DUNS | 021675699 |
| Company Name | ADVANCED NEUROMODULATION SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
| Handling Environment Temperature | Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Excursions Temperature Limits: -20C - 60C. |
| Storage Environment Temperature | Between 23 Degrees Celsius and 23 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067047663 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P140009
FDA Product Code
| PJS | Stimulator, electrical, implanted, for essential tremor |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-26 |
| Device Publish Date | 2024-02-16 |
Devices Manufactured by ADVANCED NEUROMODULATION SYSTEMS, INC.
| 05415067047663 - Liberta RC™ | 2024-02-26Implantable Pulse Generator |
| 05415067047663 - Liberta RC™ | 2024-02-26 Implantable Pulse Generator |
| 05415067047670 - NA | 2024-02-26 Charger Kit, Pectoral |
| 05414734402477 - SJM™ | 2020-02-06 |
| 05414734402613 - Eon Mini™ | 2020-02-06 Charging System Charger |
| 05414734402620 - Eon Mini™ | 2020-02-06 |
| 05414734405300 - Eon Mini LE™ | 2020-02-06 |
| 05414734405324 - Eon Mini LE™ | 2020-02-06 |
| 05415067023803 - SJM™ | 2018-10-22 Clinician Programmer App |
Trademark Results [Liberta RC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIBERTA RC 97698607 not registered Live/Pending |
St. Jude Medical, LLC 2022-11-30 |
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