Fisher & Paykel Healthcare

FDA UDI

Class II (US FDA UDI)

by Fisher & Paykel Healthcare, Inc.

Identity

Trade Name: Fisher & Paykel Healthcare FDA UDI
Generic Name: Transcutaneous electrical stimulation lead FDA UDI
Device Name: Nerve stimulator lead pin type FDA UDI
Model / Reference: 200NS032 FDA UDI
Description: Nerve stimulator lead pin type FDA UDI

Identifiers

Catalog Number: 200NS032 FDA UDI
Primary DI / UDI-DI: 09420012400871 FDA UDI
510(k) Number: K953205 FDA UDI
FDA Product Code: KOI FDA UDI
GMDN Term: Transcutaneous electrical stimulation lead FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2775 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transcutaneous electrical stimulation lead

Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K953205 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fisher & Paykel Healthcare, Inc.

Sources (1)

FDA UDI 24dd865a-36c0-4381-863a-b9a70cf4b16d 36 fields · synced May 30, 2026