ITREL® EZ ™
GUDID 00673978933733
PROGRAMMER 7434A ITREL 3 PATIENT
MEDTRONIC, INC.
Active-implantable-device communicator| Primary Device ID | 00673978933733 |
| NIH Device Record Key | 6069c610-eeef-40f5-98cf-9b36cfab4f0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ITREL® EZ ™ |
| Version Model Number | 7434A |
| Company DUNS | 796986144 |
| 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 | false |
| Single Use | false |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -40 Degrees Celsius and 65 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00673978933733 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P840001
FDA Product Code
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
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 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000613617 - Mosaic™7308C | 2025-03-11 SIZERS 7308C MOSAIC CINCH AORTIC MDR |
| 00763000613624 - Mosaic Ultra™7308U | 2025-03-11 SIZERS 7308U MOSAIC ULTRA AORTIC MDR |
| 00763000613631 - Mosaic™7310 | 2025-03-11 OBTURATORS 7310 MOSAIC MITRAL MDR |
| 00763000613648 - NA | 2025-03-11 HANDLE 7639 VALVE MDR |
| 00763000613655 - NA | 2025-03-11 HANDLE 7639XL VALVE XL MDR |
| 00763000613662 - NA | 2025-03-11 ACCESSORY 7642 LOCK NUT MDR |
| 00763000614034 - Hancock™ II 7505 | 2025-03-11 OBTURATOR 7505SET HK II AORTIC MDR |
| 00763000614041 - Hancock™ II 7510 | 2025-03-11 OBTURATOR 7510SET HK II MITRAL MDR |
Trademark Results [ITREL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ITREL 73629635 1446216 Dead/Cancelled |
MEDTRONIC, INC. 1986-11-10 |
 ITREL 73422274 1313304 Live/Registered |
Medtronic, Inc. 1983-04-18 |
 ITREL 73184208 1166349 Dead/Cancelled |
Medtronic, Inc. 1978-08-31 |
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