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Nevro

FDA UDI

Class III (US FDA UDI)

by Nevro Corporation

Identity

Trade Name
Nevro FDA UDI
Generic Name
Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Passing Elevator Accessory Tool FDA UDI
Model / Reference
ACCK2100 FDA UDI
Description
Passing Elevator Accessory Tool FDA UDI

Identifiers

Catalog Number
ACCK2100 FDA UDI
Primary DI / UDI-DI
00813426020411 FDA UDI
PMA Number
P130022 FDA UDI
FDA Product Code
LGW FDA UDI
GMDN Term
Neurosurgical procedure kit, non-medicated, single-use 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Category: Neurosurgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as Neurosurgical procedure kit, non-medicated, single-use.

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 6e1545ec-314c-4db6-bb31-d003f289f172 36 fields · synced May 30, 2026