Lamitrode™ 3268
GUDID 05414734406277
ST. JUDE MEDICAL, INC.
Analgesic spinal cord electrical stimulation system| Primary Device ID | 05414734406277 |
| NIH Device Record Key | 81066c14-d6e0-4d06-a8c9-5eceffe6c009 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lamitrode™ |
| Version Model Number | 3268 |
| Catalog Number | 3268 |
| 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 | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
| Length | 90 Centimeter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| 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 |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734406277 [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 [Lamitrode™]
| 05415067018144 | 3243 |
| 05415067017833 | 3286 |
| 05415067017703 | 3283 |
| 05415067017697 | 3268 |
| 05415067017611 | 3266 |
| 05415067017598 | 3246 |
| 05415067017543 | 3245 |
| 05414734406291 | 3286 |
| 05414734406277 | 3268 |
| 05414734406253 | 3246 |
| 05414734406239 | 3262 |
| 05414734406222 | 3245 |
| 05414734406208 | 3243 |
| 05414734406192 | 3240 |
| 05414734402088 | 3245 |
Trademark Results [Lamitrode]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAMITRODE 73663375 1470567 Live/Registered |
NEUROMED, INC. 1987-05-28 |
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