Identity
- Trade Name
- CUSTOM SOUND PRO 7.0 CD FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Model / Reference
- P2002452CD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09321502074148 FDA UDI
- PMA Number
- P970051 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Audiometric/hearing device 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Audiometric/hearing device software
Custom Sound Pro 7.0 Cd by Cochlear Americas — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
- CUSTOM SND SUITE 1.3 SERV RELEASE 1 — Cochlear · Class III
- Boots Hearingcare 2 — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- Widex — Widex A/S · Class I
- Nucleus — Cochlear · Class III
- hearX — INTRICON CORPORATION · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
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 Americas
Sources (1)
- FDA UDI 5b9e9930-0b36-4729-87f6-36e4f2a4ec5d 34 fields · synced May 30, 2026