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Nalu Medical, Inc.

FDA UDI

Class II (US FDA UDI)

by Nalu Medical

Identity

Trade Name
Nalu Medical, Inc. FDA UDI
Generic Name
Implantable electrical stimulation device management software FDA UDI
Device Name
SCS Remote App (compatible with iOS) FDA UDI
Model / Reference
53002-002 FDA UDI
Description
SCS Remote App (compatible with iOS) FDA UDI

Identifiers

Catalog Number
53002-002 FDA UDI
Primary DI / UDI-DI
00812537033013 FDA UDI
FDA Product Code
GZF FDA UDI
GZB FDA UDI
GMDN Term
Implantable electrical stimulation device management software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5870 FDA UDI
882.5880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Implantable electrical stimulation device management software

Nalu Medical, Inc. by Nalu Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable electrical stimulation device management software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nalu Medical

Sources (1)

  • FDA UDI 9f2e9213-8c9b-4427-a5d9-81e77b0eb2d9 35 fields · synced May 30, 2026