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Osia® 2 Sound Processor Magnet Tool

FDA UDI

Class II (US FDA UDI)

by Cochlear

Identity

Trade Name
Osia® 2 Sound Processor Magnet Tool FDA UDI
Generic Name
Hearing implant system external magnet inserter/remover FDA UDI
Model / Reference
Osia 2 System FDA UDI

Identifiers

Catalog Number
P1631253 FDA UDI
Primary DI / UDI-DI
09321502046626 FDA UDI
510(k) Number
K191921 FDA UDI
FDA Product Code
PFO FDA UDI
GMDN Term
Hearing implant system external magnet inserter/remover 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hearing implant system external magnet inserter/remover

Osia® 2 Sound Processor Magnet Tool by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K191921 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear

Sources (1)

  • FDA UDI 18f92f05-3b16-467d-9923-1aee5d066c2d 36 fields · synced Jun 6, 2026