CapSureFix Novus MRI™ SureScan™
GUDID 00643169708174
LEAD 407635 CAPSUREFIX NOVUS US MRI
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00643169708174 |
| NIH Device Record Key | 8169fae4-7850-40ae-8634-fe9cd6192b1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CapSureFix Novus MRI™ SureScan™ |
| Version Model Number | 407635 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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 | false |
| 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
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169708174 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P930039
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 | 2018-07-06 |
| Device Publish Date | 2016-12-26 |
On-Brand Devices [CapSureFix Novus MRI™ SureScan™]
| 00643169708228 | LEAD 407685 CAPSUREFIX NOVUS US MRI |
| 00643169708211 | LEAD 407665 CAPSUREFIX NOVUS US MRI |
| 00643169708204 | LEAD 407658 CAPSUREFIX NOVUS US MRI |
| 00643169708198 | LEAD 407652 CAPSUREFIX NOVUS US MRI |
| 00643169708181 | LEAD 407645 CAPSUREFIX NOVUS US MRI |
| 00643169708174 | LEAD 407635 CAPSUREFIX NOVUS US MRI |
| 00763000014728 | LEAD 5076-85 MRI US RCMCRD |
| 00763000014711 | LEAD 5076-65 MRI US RCMCRD |
| 00763000014704 | LEAD 5076-58 MRI US RCMCRD |
| 00763000014698 | LEAD 5076-52 MRI US RCMCRD |
| 00763000014681 | LEAD 5076-45 MRI US RCMCRD |
| 00763000014674 | LEAD 407685 CAPSUREFIX MRI US RCMCRD |
| 00763000014667 | LEAD 407665 CAPSUREFIX MRI US RCMCRD |
| 00763000014650 | LEAD 407658 CAPSUREFIX MRI US RCMCRD |
| 00763000014643 | LEAD 407652 CAPSUREFIX MRI US RCMCRD |
| 00763000014636 | LEAD 407645 CAPSUREFIX MRI US RCMCRD |
Trademark Results [CapSureFix Novus MRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSUREFIX NOVUS MRI 85724832 4863497 Live/Registered |
Medtronic, Inc. 2012-09-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.