Siello 362706
GUDID 04035479106263
BIOTRONIK SE & Co. KG
Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead| Primary Device ID | 04035479106263 |
| NIH Device Record Key | 27bc9476-5c32-4058-b75d-c1f0faab6923 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Siello |
| Version Model Number | T 60 |
| Catalog Number | 362706 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| 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 | 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479106263 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950037
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 | 2 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2018-08-30 |
On-Brand Devices [Siello]
| 04035479106263 | T 60 |
| 04035479106256 | T 53 |
| 04035479106249 | JT 53 |
| 04035479106232 | JT 45 |
Trademark Results [Siello]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIELLO 77680978 4033065 Live/Registered |
BIOTRONIK SE & CO. KG 2009-03-01 |
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