Liberta RC™ 62400
GUDID 05415067047663
Implantable Pulse Generator
ADVANCED NEUROMODULATION SYSTEMS, INC.
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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