Identity
- Trade Name
- Nucleus FDA UDI
- Generic Name
- Cochlear implant system electrode array assembly FDA UDI
- Device Name
- Cochlear Nucleus Hybrid L24 cochlear implant FDA UDI
- Model / Reference
- Z60988 FDA UDI
- Description
- Cochlear Nucleus Hybrid L24 cochlear implant FDA UDI
Identifiers
- Catalog Number
- Z60988 FDA UDI
- Primary DI / UDI-DI
- 09321502012089 FDA UDI
- PMA Number
- P130016 FDA UDI
- FDA Product Code
- PGQ 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
FDA UDI
Single Use
No
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
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Category: Cochlear implant system electrode array assembly
Nucleus by Cochlear — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI 3a642c08-8d96-4f26-8be5-23f8e055c72f 37 fields · synced Jun 1, 2026