Identity
- Trade Name
- Cochlear FDA UDI
- Generic Name
- Cochlear implant/auditory brainstem implant sound processor/coil decorative cover FDA UDI
- Device Name
- CP1000 5 (I) MAGNET COVER (SAND), PACKED FDA UDI
- Model / Reference
- P1624190 FDA UDI
- Description
- CP1000 5 (I) MAGNET COVER (SAND), PACKED FDA UDI
Identifiers
- Catalog Number
- P1624190 FDA UDI
- Primary DI / UDI-DI
- 09321502046480 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant/auditory brainstem implant sound processor/coil decorative 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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/auditory brainstem implant sound processor/coil decorative cover
Cochlear by Cochlear — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cochlear implant/auditory brainstem implant sound processor/coil decorative cover.
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 5eee85e8-6ac3-4f86-9f54-e8e52abd8be5 35 fields · synced Jun 8, 2026