Penta™ 3228
GUDID 05414734406246
ST. JUDE MEDICAL, INC.
Analgesic spinal cord electrical stimulation system Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection| Primary Device ID | 05414734406246 |
| NIH Device Record Key | a1cf0e11-264d-4bf9-9e93-2a5dfbfb479f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Penta™ |
| Version Model Number | 3228 |
| Catalog Number | 3228 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, 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 | true |
| 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 |
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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
| Length | 60 Centimeter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734406246 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010032
FDA Product Code
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-03-11 |
On-Brand Devices [Penta™]
| 05415067017253 | 3228 |
| 05414734406246 | 3228 |
Trademark Results [Penta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PENTA 97719328 not registered Live/Pending |
Ellis, Kirk P. 2022-12-15 |
 PENTA 97005128 not registered Live/Pending |
Penta Motorsports Inc. 2021-08-31 |
 PENTA 90354791 not registered Live/Pending |
Hearth Products Controls Co. 2020-12-02 |
 PENTA 90342868 not registered Live/Pending |
Ogassian, Inc. 2020-11-25 |
 PENTA 90068906 not registered Live/Pending |
Penta S.r.l. 2020-07-23 |
 PENTA 88672877 not registered Live/Pending |
Zegen LLC 2019-10-29 |
 PENTA 88335734 5867542 Live/Registered |
PENTA AUTOMAZIONI INDUSTRIALI S.R.L 2019-03-12 |
 PENTA 88163105 5763102 Live/Registered |
HYDRATION TECHNOLOGY GROUP, INC. 2018-10-21 |
 PENTA 87040205 5829276 Live/Registered |
Penta Brands, LLC 2016-05-17 |
 PENTA 86766029 not registered Dead/Abandoned |
LG ELECTRONICS INC. 2015-09-23 |
 PENTA 86272087 4710925 Live/Registered |
PENTA Engineering Corp. 2014-05-05 |
 PENTA 86272068 4706946 Live/Registered |
PENTA Engineering Corp. 2014-05-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.