RESUME II
GUDID 00613994354358
LEAD KIT 3587A25 Resume ll SCS/PNS 25CM
MEDTRONIC, INC.
Neural-tissue electrical stimulation lead Neural-tissue electrical stimulation lead Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection| Primary Device ID | 00613994354358 |
| NIH Device Record Key | 1c8a37e8-55b6-4b91-9054-1147ffc60194 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESUME II |
| Version Model Number | 3587A25 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
Device Dimensions
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
| Length | 25 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994354358 [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 | 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 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000951825 - NA | 2024-05-31 CUSTOM PACK SSBB12G88R STERILE SMPL |
| 00763000953423 - NA | 2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK |
| 00763000953614 - NA | 2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN |
| 00763000953621 - NA | 2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC |
| 00763000953638 - NA | 2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP |
| 00763000953645 - NA | 2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP |
| 20763000953663 - NA | 2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL |
| 00763000953676 - NA | 2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK |
Trademark Results [RESUME II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESUME II 74048301 1698922 Live/Registered |
Medtronic, Inc. 1990-04-12 |
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