DEVICE: Surpass (00813426020589)
Device Identifier (DI) Information
Surpass
LEAD2005-70B
In Commercial Distribution
LEAD2005-70B
NEVRO CORP.
LEAD2005-70B
In Commercial Distribution
LEAD2005-70B
NEVRO CORP.
Surpass-C Surgical Lead Kit, 70cm
Device Characteristics
MR Unsafe | |
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 |
---|---|
LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P130022 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
573fd3a0-30f9-4b1a-a02b-913a18b5880b
June 08, 2021
4
April 08, 2020
June 08, 2021
4
April 08, 2020
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
[?]
650-251-0005
info@nevro.com
info@nevro.com