CapSure®SP Novus
GUDID 00681490110716
LEAD 4092-58 CAPSURE BI HYBRID 58CM US
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00681490110716 |
| NIH Device Record Key | aa92a05c-5594-4527-b19b-291c5928d180 |
| Commercial Distribution Discontinuation | 2018-09-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CapSure®SP Novus |
| Version Model Number | 4092-58 |
| 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 | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 Centimeter |
| Length | 58 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 | 00681490110716 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P830061
FDA Product Code
| NVY | Permanent defibrillator 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 | 2018-09-11 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [CapSure®SP Novus]
| 00613994250230 | LEAD 559445 FPA BI SIL ATR STER US |
| 00613994250223 | LEAD 559453 FPA BI SIL ATR STER US |
| 00643169590762 | LEAD 559458 CAPSURE SP US BI SIL ATRL |
| 00643169590755 | LEAD 559453 CAPSURE SP US BI SIL ATRL |
| 00643169590748 | LEAD 559445 CAPSURE SP US BI SIL ATRL |
| 00643169590731 | LEAD 5592-53 CAPSURE SP US BI SIL ATRL |
| 00643169590724 | LEAD 5592-45 CAPSURE SP US BI SIL ATRL |
| 00643169590700 | LEAD 509285 CAPSURE SP US BI SIL VENT |
| 00643169590694 | LEAD 5092-65 CAPSURE SP US BI SIL VENT |
| 00643169590687 | LEAD 5092-58 CAPSURE SP US BI SIL VENT |
| 00643169590670 | LEAD 5092-52 CAPSURE SP US BI SIL VENT |
| 00643169590663 | LEAD 5092-45 CAPSURE SP US BI SIL VENT |
| 00681490135733 | LEAD 5592-53 STEROID BIP SILICONE ATRL |
| 00681490135696 | LEAD 5592-45 CAPSURE SP NOVUS US |
| 00681490125109 | LEAD 5092-58 BIP SILICONE VENT STEROID |
| 00681490125048 | LEAD 5092-52 BIP SILICONE VENT STEROID |
| 00681490114974 | LEAD 4592-53 BI HYBR CAPSURE US PAS 53CM |
| 00681490114943 | LEAD 4592-45 CAPSURE BIP HYB DPLS PAS |
| 00681490110778 | LEAD 4092-65 CAPSURE SP BIP HYBRID |
| 00681490110716 | LEAD 4092-58 CAPSURE BI HYBRID 58CM US |
| 00681490110655 | LEAD 4092-52 CAPSURE SP NOVUS US |
Trademark Results [CapSure]
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