Identity
- Trade Name
- Nucleus FDA UDI
- Generic Name
- Cochlear implant system electrode array assembly FDA UDI
- Device Name
- Cochlear Nucleus CI512 cochlear implant with Contour Advance electrode FDA UDI
- Model / Reference
- Z209051 FDA UDI
- Description
- Cochlear Nucleus CI512 cochlear implant with Contour Advance electrode FDA UDI
Identifiers
- Catalog Number
- Z209051 FDA UDI
- Primary DI / UDI-DI
- 09321502014564 FDA UDI
- PMA Number
- P970051 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant system electrode array assembly FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Cochlear implant system electrode array assembly
A comprehensive cochlear implant system electrode array assembly for individuals with severe to profound hearing loss. The Nucleus CI512 implant features an electrically-powered electrode array surgically implanted in one cochlea, and a receiver-stimulator implanted near the ear and connected to the electrode array.
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Cleared under the same submission
P970051 also covers:
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- Cochlear™ Compact Battery Module — Cochlear
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI fc39ce1b-8414-4bd3-b8bf-9204fcf9522e 37 fields · synced Jul 17, 2026