Siello 362703
GUDID 04035479106232
BIOTRONIK SE & Co. KG
Endocardial pacing lead| Primary Device ID | 04035479106232 |
| NIH Device Record Key | 56bd591f-e8ae-4e78-8b59-8dd9895443d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Siello |
| Version Model Number | JT 45 |
| Catalog Number | 362703 |
| 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
| 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 |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479106232 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.