ReActiv8 Magnet

FDA UDI

Class III (US FDA UDI)

by Mainstay Medical Limited

Identity

Trade Name: ReActiv8 Magnet FDA UDI
Generic Name: Active implantable device control magnet FDA UDI
Device Name: ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming). FDA UDI
Model / Reference: 6M4000-004 FDA UDI
Description: ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming). FDA UDI

Identifiers

Catalog Number: 4000 FDA UDI
Primary DI / UDI-DI: 05391527770633 FDA UDI
PMA Number: P190021 FDA UDI
FDA Product Code: QLK FDA UDI
GMDN Term: Active implantable device control magnet FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Active implantable device control magnet

ReActiv8 Magnet by Mainstay Medical Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Active implantable device control magnet.

VITARIA™ Patient Essentials, Model 7220 — LivaNova USA, Inc. · Class I
Magnet — Neuropace, Inc. · Class III
Senza — Nevro Corporation · Class III
BIOTRONIK — BIOTRONIK SE & Co. KG · Class III
Cyberonics® Patient Magnet — LivaNova USA, Inc. · Class I
Algovita® — Greatbatch Ltd · Class III
Axium™ — ST. JUDE MEDICAL, INC. · Class III

Cleared under the same submission

P190021 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 III	Pending data

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Manufacturer

Manufacturer: Mainstay Medical Limited

Sources (1)

FDA UDI 5253d450-26ad-42d4-af50-9941020752c5 35 fields · synced Jun 1, 2026