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Nevro®

FDA UDI

Class III (US FDA UDI)

by Nevro Corporation

Identity

Trade Name
Nevro® FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension FDA UDI
Device Name
Blue Lead Extension Kit, 35cm Downsized FDA UDI
Model / Reference
LEAD2008-35B FDA UDI
Description
Blue Lead Extension Kit, 35cm Downsized FDA UDI

Identifiers

Primary DI / UDI-DI
00813426020831 FDA UDI
PMA Number
P130022 FDA UDI
FDA Product Code
LGW FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension

Nevro® by Nevro Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension.

Cleared under the same submission

P130022 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nevro Corporation

Sources (1)

  • FDA UDI bc617eb8-8059-4808-9478-27a3de53899f 35 fields · synced May 30, 2026