SUREFIX®
GUDID 00885074311876
LEAD 5072-52 SUREFIX PACING LEAD US
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00885074311876 |
| NIH Device Record Key | 4d9b78ef-182e-4c08-9ae4-20fa5e59ad3e |
| Commercial Distribution Discontinuation | 2015-10-26 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SUREFIX® |
| Version Model Number | 5072-52 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885074311876 [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 | 2014-09-23 |
On-Brand Devices [SUREFIX®]
| 00885074311883 | LEAD 5072-58 SUREFIX PACING LEAD US |
| 00885074311876 | LEAD 5072-52 SUREFIX PACING LEAD US |
| 00885074311869 | LEAD 5072-45 SUREFIX PACING LEAD US |
Trademark Results [SUREFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUREFIX 97303287 not registered Live/Pending |
Surefix Solutions, L.L.C. 2022-03-09 |
 SUREFIX 97106981 not registered Live/Pending |
Orsini, Jean-Francois 2021-11-03 |
 SUREFIX 88124178 not registered Live/Pending |
HEMISPHERE GNSS, INC. 2018-09-19 |
 SUREFIX 87126821 not registered Dead/Abandoned |
HEMISPHERE GNSS, INC. 2016-08-04 |
 SUREFIX 77696714 3695417 Live/Registered |
Comfort Systems USA 2009-03-23 |
 SUREFIX 75402436 2251999 Live/Registered |
Medtronic, Inc. 1997-12-09 |
 SUREFIX 74316640 not registered Dead/Abandoned |
ACUFEX MICROSURGICAL, INC. 1992-09-24 |
 SUREFIX 74070699 not registered Dead/Abandoned |
ACUFEX MICROSURGICAL, INC. 1990-06-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.