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Osia® 2 Sound Processor Magnet Pack (strength 2)
FDA UDIClass II (US FDA UDI)
by Cochlear
Identity
- Trade Name
- Osia® 2 Sound Processor Magnet Pack (strength 2) FDA UDI
- Generic Name
- Hearing implant system external magnet, reusable FDA UDI
- Model / Reference
- Osia 2 System FDA UDI
Identifiers
- Catalog Number
- P1631252 FDA UDI
- Primary DI / UDI-DI
- 09321502046596 FDA UDI
- 510(k) Number
- K191921 FDA UDI
- FDA Product Code
- PFO FDA UDI
- GMDN Term
- Hearing implant system external magnet, reusable 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
No
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, reusable
Osia® 2 Sound Processor Magnet Pack (strength 2) by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing implant system external magnet, reusable.
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- Slim HP 3D Magnet 3 — Advanced Bionics · Class III
- 3D Magnet — Advanced Bionics · Class III
- Slim HP Standard Magnet — Advanced Bionics · Class III
Cleared under the same submission
K191921 also covers:
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear™ Sterile Non-Magnetic Plug — Cochlear
- Cochlear™ Sterile Replacement Magnet — Cochlear
- Osia® 2 Aqua+ — Cochlear
- Osia® 2 Sound Processor Magnet Pack (strength 1) — Cochlear
- Osia® 2 Sound Processor Magnet Pack (strength 3) — Cochlear
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI 49a7b884-5f45-433d-a710-8e7732ab133a 36 fields · synced May 30, 2026