DEVICE: ON-POINT® (00673978926452)
Device Identifier (DI) Information
ON-POINT®
3987A
In Commercial Distribution
MEDTRONIC, INC.
3987A
In Commercial Distribution
MEDTRONIC, INC.
LEAD 3987A ON-POINT 1X4 PNS 25CM ID
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62423 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection |
An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K040568 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -34 and 57 Degrees Celsius |
Storage Environment Temperature: between -30 and 135 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9df27028-0f1d-4efb-baeb-dd00a7b00f91
July 31, 2023
4
June 08, 2015
July 31, 2023
4
June 08, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com