CapSureFix MRI™ SureScan™
GUDID 00613994657350
LEAD 5086MRI45 US MARKET EN
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00613994657350 |
| NIH Device Record Key | 2da4a6c4-58cc-432c-8ec8-e4f63dac00b9 |
| Commercial Distribution Discontinuation | 2018-04-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CapSureFix MRI™ SureScan™ |
| Version Model Number | 5086MRI45 |
| 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 | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 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 | 00613994657350 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P090013
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 | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [CapSureFix MRI™ SureScan™]
| 00613994657374 | LEAD 5086MRI58 US MARKET EN |
| 00613994657367 | LEAD 5086MRI52 US MARKET EN |
| 00613994657350 | LEAD 5086MRI45 US MARKET EN |
| 00643169551008 | LEAD 5086MRI58 US |
| 00643169550995 | LEAD 5086MRI52 US |
| 00643169550988 | LEAD 5086MRI45 US |
Trademark Results [CapSureFix MRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSUREFIX MRI 77244156 3864796 Live/Registered |
Medtronic, Inc. 2007-08-01 |
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