Cochlear™ Magnet Cassette

FDA UDI

Class II (US FDA UDI)

by Cochlear

Identity

Trade Name: Cochlear™ Magnet Cassette FDA UDI
Generic Name: Cochlear implant implantable magnet FDA UDI
Model / Reference: P1773917 FDA UDI

Identifiers

Catalog Number: P1773917 FDA UDI
Primary DI / UDI-DI: 09321502070683 FDA UDI
510(k) Number: K231204 FDA UDI
FDA Product Code: PFO FDA UDI
GMDN Term: Cochlear implant implantable magnet FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.3340 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cochlear implant implantable magnet

Cochlear™ Magnet Cassette by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cochlear implant implantable magnet.

HiRes™ Ultra 3D Replacement Magnet — Advanced Bionics · Class III
HiRes 90K™ Replacement Magnet — Advanced Bionics · Class III
CI24RE Series Sterile Replacement Magnet — Cochlear · Class III
CI500 Series Sterile Replacement Magnet — Cochlear · Class III
Cochlear™ Sterile Replacement Magnet — Cochlear · Class II

Cleared under the same submission

K231204 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: Cochlear

Sources (1)

FDA UDI a656c8f9-8848-426d-a328-5939a8ee0c3a 35 fields · synced May 30, 2026