Identity
- Trade Name
- Kanso® 2 Microphone Cover FDA UDI
- Generic Name
- Cochlear implant system sound processor microphone cover FDA UDI
- Device Name
- Chocolate Brown FDA UDI
- Model / Reference
- P1376466 FDA UDI
- Description
- Chocolate Brown FDA UDI
Identifiers
- Catalog Number
- P1376466 FDA UDI
- Primary DI / UDI-DI
- 09321502045384 FDA UDI
- PMA Number
- P970051 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant system sound processor microphone cover 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cochlear implant system sound processor microphone cover
Kanso® 2 Microphone Cover by Cochlear — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant system sound processor microphone cover.
- Cochlear™ Microphone Cover — Cochlear · Class III
- Cochlear™ Microphone Cover — Cochlear · Class III
- Cochlear™ Kanso® 3 Microphone Cover — Cochlear · Class III
- Cochlear™ Microphone Cover — Cochlear · Class III
- Kanso® 2 Microphone Cover — Cochlear · Class III
- Cochlear™ Kanso® 3 Microphone Cover — Cochlear · Class III
- Cochlear™ Microphone Cover — Cochlear · Class III
- Kanso® 2 Microphone Cover — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cochlear
Sources (1)
- FDA UDI e0952c4f-54fa-4ec0-981e-6eb4195f75ec 36 fields · synced May 30, 2026