Solox 333900
GUDID 04035479049218
BIOTRONIK SE & Co. KG
Endocardial pacing lead| Primary Device ID | 04035479049218 |
| NIH Device Record Key | 87d2515d-3ce5-4c36-9324-170f4fd04fb3 |
| Commercial Distribution Discontinuation | 2020-10-16 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Solox |
| Version Model Number | SLX 58/13-BP |
| Catalog Number | 333900 |
| 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 | false |
| 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 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479049218 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950037
FDA Product Code
| DTB | permanent pacemaker Electrode |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-10-19 |
| Device Publish Date | 2014-08-21 |
On-Brand Devices [Solox]
| 04035479049232 | SLX 58/15-BP |
| 04035479049218 | SLX 58/13-BP |
Trademark Results [Solox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLOX 98640807 not registered Live/Pending |
Alberta Veterinary Laboratories Ltd. 2024-07-10 |
 SOLOX 97424034 not registered Live/Pending |
Stillwater Designs and Audio, Inc 2022-05-23 |
 SOLOX 88520407 not registered Live/Pending |
NewBorn-Town Network Technology (Beijing) Co., Ltd. 2019-07-17 |
 SOLOX 88520385 not registered Live/Pending |
NewBorn-Town Network Technology (Beijing) Co., Ltd. 2019-07-17 |
 SOLOX 88139591 not registered Live/Pending |
Stillwater Designs and Audio, Inc. 2018-10-02 |
 SOLOX 86750648 5009512 Live/Registered |
LAM International Corporation 2015-09-08 |
 SOLOX 77086308 3625126 Dead/Cancelled |
Stillwater Designs and Audio, Inc. 2007-01-19 |
 SOLOX 75410243 2396724 Dead/Cancelled |
BIOTRONIK SE & CO. KG 1997-12-23 |
 SOLOX 74290306 1759326 Dead/Cancelled |
Interox International (Societe Anonyme) 1992-07-01 |
 SOLOX 74269751 1881381 Dead/Cancelled |
Solar Kinetics, Inc. 1992-04-24 |
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