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Osia OSI300 Implant

FDA UDI

Class II (US FDA UDI)

by Cochlear

Identity

Trade Name
Osia OSI300 Implant FDA UDI
Generic Name
Bone-conduction hearing implant system vibrator assembly FDA UDI
Model / Reference
P1772248 FDA UDI

Identifiers

Catalog Number
P1772248 FDA UDI
Primary DI / UDI-DI
09321502070676 FDA UDI
510(k) Number
K231204 FDA UDI
FDA Product Code
PFO FDA UDI
GMDN Term
Bone-conduction hearing implant system vibrator assembly 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

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Bone-conduction hearing implant system vibrator assembly

Osia OSI300 Implant by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-conduction hearing implant system vibrator assembly.

Cleared under the same submission

K231204 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 ff4cee11-868f-44c9-90b7-3398a28457f9 35 fields · synced May 30, 2026