DEVICE: Surpass (00813426020589)

Device Identifier (DI) Information

Surpass
LEAD2005-70B
In Commercial Distribution
LEAD2005-70B
NEVRO CORP.
00813426020589
GS1

1
926599155 *Terms of Use
Surpass-C Surgical Lead Kit, 70cm
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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
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FDA Product Code

[?]
Product Code Product Code Name
LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P130022 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

573fd3a0-30f9-4b1a-a02b-913a18b5880b
June 08, 2021
4
April 08, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
650-251-0005
info@nevro.com
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