Capsurefix® Novus
GUDID 00613994329387
LEAD 407635 CAPSFIX NOVUS ACTBI PLY STRT
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00613994329387 |
| NIH Device Record Key | b6fbd9b6-85ef-48a9-9e24-bd0632f0d38b |
| Commercial Distribution Discontinuation | 2018-06-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Capsurefix® Novus |
| Version Model Number | 407635 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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 | 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
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994329387 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P930039
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [Capsurefix® Novus]
| 00613994329400 | LEAD 407685 CAPSFIX NOVUS ACTBI PLY STRT |
| 00613994329394 | LEAD 407665 CAPSFIX NOVUS ACTBI PLY STRT |
| 00613994329387 | LEAD 407635 CAPSFIX NOVUS ACTBI PLY STRT |
| 00643169550872 | LEAD 407625 CAPSUREFIX NOVUS PACE US |
| 00643169550865 | LEAD 4076110 CAPSUREFIX NOVUS PACE US |
| 00643169550858 | LEAD 407685 CAPSUREFIX NOVUS PACE US |
| 00643169550841 | LEAD 407665 CAPSUREFIX NOVUS PACE US |
| 00643169550834 | LEAD 407635 CAPSUREFIX NOVUS PACE US |
| 00643169550827 | LEAD 407658 CAPSUREFIX NOVUS PACE US |
| 00643169550810 | LEAD 407652 CAPSUREFIX NOVUS PACE US |
| 00643169550803 | LEAD 407645 CAPSUREFIX NOVUS PACE US |
| 00681490730099 | LEAD 5076-85 STERIOD SCR-IN SIL BIP |
| 00681490730068 | LEAD 5076-65 BI SIL SCR-IN STER US EN |
| 00681490729963 | LEAD 5076-35 CAPSURE FIX NOVUS US |
| 00681490124867 | LEAD 5076-58 CAPSUREFIX NOVUS US EN |
| 00681490124812 | LEAD 5076-52 CAPSUREFIX NOVUS US EN |
| 00681490124799 | LEAD 5076-45 CAPSUREFIX NOVUS US EN |
| 00721902309656 | LEAD 5076110 SM BI SIL SCR-IN STER |
| 00885074200699 | LEAD 407658 CAPSUREFIX NOVUS PACE US |
| 00885074200682 | LEAD 407652 CAPSUREFIX NOVUS PACE US |
| 00885074200675 | LEAD 407645 CAPSUREFIX NOVUS PACE US |
Trademark Results [Capsurefix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSUREFIX 74330839 1841274 Live/Registered |
Medtronic, Inc. 1992-11-13 |
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