Setrox 350973
GUDID 04035479087944
BIOTRONIK SE & Co. KG
Endocardial pacing lead| Primary Device ID | 04035479087944 |
| NIH Device Record Key | 376cfbb6-4680-436b-9c66-7c5d932fc108 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Setrox |
| Version Model Number | S 45 |
| Catalog Number | 350973 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| 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 | true |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
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Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F. |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479087944 [Primary] |
FDA Product Code
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2014-08-19 |
On-Brand Devices [Setrox]
| 04035479087968 | S 60 |
| 04035479087951 | S 53 |
| 04035479087944 | S 45 |
Trademark Results [Setrox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SETROX 78635407 3290337 Live/Registered |
BIOTRONIK SE & CO. KG 2005-05-23 |
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