INTELLAGEN™ Foot Pedal M004GEN100200100
GUDID 04260166373066
Stockert GmbH
Foot-switch, electrical| Primary Device ID | 04260166373066 |
| NIH Device Record Key | 7e713e70-84c8-4522-982a-832fa1c6c6b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTELLAGEN™ Foot Pedal |
| Version Model Number | 20010 |
| Catalog Number | M004GEN100200100 |
| Company DUNS | 327536314 |
| Company Name | Stockert GmbH |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com | |
| Phone | +1-888-272-1001 |
| CETechSupportUSA@bsci.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 22 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry; Fragile, handle with care |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260166373066 [Primary] |
FDA Product Code
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
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 | 2024-09-09 |
| Device Publish Date | 2024-09-01 |
Devices Manufactured by Stockert GmbH
| 04260166373066 - INTELLAGEN™ Foot Pedal | 2024-09-09 |
| 04260166373066 - INTELLAGEN™ Foot Pedal | 2024-09-09 |
| 04260166373080 - INTELLAGEN™ Grounding Cable (3m) | 2024-09-09 |
| 04260166373097 - INTELLAGEN™ ECG Connection Cable (3m) | 2024-09-09 |
| 04260166373103 - INTELLAGEN™ Serial Communication Cable (5m) | 2024-09-09 |
| 04260166373110 - INTELLAGEN™ Serial Communication Cable (15m) | 2024-09-09 |
| 04260166373127 - INTELLAGEN™ Remote Control Connection Cable (25m) | 2024-09-09 |
| 04260166373134 - INTELLAGEN™ Irrigation Pump Connection Cable (5m) | 2024-09-09 |
| 04260166373158 - INTELLAGEN™ Catheter Adapter Cable (0.3m) | 2024-09-09 |
Trademark Results [INTELLAGEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTELLAGEN 98550182 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2024-05-14 |
 INTELLAGEN 98087988 not registered Live/Pending |
Jaquish Biomedical Corporation 2023-07-17 |
 INTELLAGEN 90332956 not registered Live/Pending |
Boston Scientific Scimed, Inc. 2020-11-20 |
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