Sentus 401181
GUDID 04035479138424
BIOTRONIK SE & Co. KG
Coronary venous pacing lead| Primary Device ID | 04035479138424 |
| NIH Device Record Key | 0a0046f5-ae6b-44a1-883f-41342463535a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sentus |
| Version Model Number | ProMRI OTW QP S-95 |
| Catalog Number | 401181 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479138424 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P070008
FDA Product Code
| OJX | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-23 |
| Device Publish Date | 2019-07-15 |
On-Brand Devices [Sentus]
| 04035479148966 | ProMRI OTW QP L-95/49 |
| 04035479145613 | ProMRI OTW QP S-95/49 |
| 04035479138455 | ProMRI OTW QP L-95 |
| 04035479138448 | ProMRI OTW QP L-85 |
| 04035479138431 | ProMRI OTW QP L-75 |
| 04035479138424 | ProMRI OTW QP S-95 |
| 04035479138417 | ProMRI OTW QP S-85 |
| 04035479138400 | ProMRI OTW QP S-75 |
| 04035479148959 | ProMRI OTW QP L-85/49 |
| 04035479148942 | ProMRI OTW QP L-75/49 |
| 04035479145606 | ProMRI OTW QP S-85/49 |
| 04035479145590 | ProMRI OTW QP S-75/49 |
Trademark Results [Sentus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENTUS 85294885 4212365 Live/Registered |
Biotronik SE & Co. KG 2011-04-14 |
 SENTUS 75854824 2520967 Dead/Cancelled |
Viniquinta - Sociedade de Comercializacao de Vinhos, Ltd. 1999-11-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.