Identity
- Trade Name
- Cochlear™ Sterile Non-Magnetic Plug FDA UDI
- Generic Name
- Cochlear implant dummy magnet FDA UDI
- Model / Reference
- P1620901 FDA UDI
Identifiers
- Catalog Number
- P1620901 FDA UDI
- Primary DI / UDI-DI
- 09321502046527 FDA UDI
- 510(k) Number
- K191921 FDA UDI
- FDA Product Code
- PFO FDA UDI
- GMDN Term
- Cochlear implant dummy 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Category: Cochlear implant dummy magnet
Cochlear™ Sterile Non-Magnetic Plug by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant dummy magnet.
Cleared under the same submission
K191921 also covers:
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear — 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 2) — 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 |
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Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI ca480776-efba-4663-af08-35e6cd021030 35 fields · synced May 30, 2026