CAPSURE SP NOVUS®
GUDID 00643169638631
LEAD 4092-52 CAPSURE SP NOVUS US
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00643169638631 |
| NIH Device Record Key | 70e8b9d1-1188-42c8-8390-000eed26e96c |
| Commercial Distribution Discontinuation | 2018-11-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CAPSURE SP NOVUS® |
| Version Model Number | 4092-52 |
| 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 | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 Centimeter |
| Length | 52 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 | 00643169638631 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P830061
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 | 4 |
| Public Version Date | 2018-12-13 |
| Device Publish Date | 2016-04-22 |
On-Brand Devices [CAPSURE SP NOVUS®]
| 00643169638723 | LEAD 4592-53 CAPSURE SP NOVUS US |
| 00643169638716 | LEAD 4592-45 CAPSURE SP NOVUS US |
| 00643169638648 | LEAD 4092-58 CAPSURE SP NOVUS US |
| 00643169638631 | LEAD 4092-52 CAPSURE SP NOVUS US |
| 00885074200996 | LEAD 4592-53 CAPSURE SP NOVUS US |
| 00885074200989 | LEAD 4592-45 CAPSURE SP NOVUS US |
Trademark Results [CAPSURE SP NOVUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSURE SP NOVUS 78071023 2675693 Live/Registered |
MEDTRONIC INC. 2001-06-26 |
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