Identity
- Trade Name
- Nucleus® SmartNav FDA UDI
- Generic Name
- Cochlear implant intraoperative electrophysiological analysis software FDA UDI
- Device Name
- Hearing implant software FDA UDI
- Model / Reference
- P1799437 FDA UDI
- Description
- Hearing implant software FDA UDI
Identifiers
- Catalog Number
- P1799437 FDA UDI
- Primary DI / UDI-DI
- 09321502065917 FDA UDI
- PMA Number
- P970051 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant intraoperative electrophysiological analysis software FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Category: Cochlear implant intraoperative electrophysiological analysis software
Nucleus® SmartNav by Cochlear — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant intraoperative electrophysiological analysis software.
- Nucleus® — Cochlear · Class III
- Cochlear™ Objective Measures — Cochlear · Class III
Cleared under the same submission
P970051 also covers:
- CP1000 Magnet (6 M, White) - Bulk Pack — Cochlear
- CUSTOM SND SUITE 1.3 SERV RELEASE 1 — Cochlear
- CUSTOM SOUND SUITE 3.2 ENGLISH (US) — Cochlear
- Cochlear — Cochlear
- Cochlear — Cochlear
- Cochlear Surgical Instrument Upgrade Kit — Cochlear
- Cochlear™ — Cochlear
- Cochlear™ CP1110S Surgical Coil — Cochlear
- Cochlear™ Compact Battery Module — Cochlear
- Cochlear™ Earhook — Cochlear
- Cochlear™ Hybrid™ Ear Lock, 85 — Cochlear
- Cochlear™ Hybrid™ Open Dome, 6 mm — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI 1cd073f7-442e-4be3-a848-b816642d77a3 36 fields · synced May 30, 2026