Identity
- Trade Name
- Custom Sound® FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Custom Sound Suite 6.1 FDA UDI
- Model / Reference
- P1764756 FDA UDI
- Description
- Custom Sound Suite 6.1 FDA UDI
Identifiers
- Catalog Number
- P1764756 FDA UDI
- Primary DI / UDI-DI
- 09321502055833 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® by Cochlear — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
- Boots Hearingcare 2 — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- Widex — Widex A/S · Class I
- hearX — INTRICON CORPORATION · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- Sonova Brand — Sonova AG · Class II
- GN Hearing — Gn Hearing A/S · 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
Sources (1)
- FDA UDI 8127b886-782f-4e37-9be5-e559dc228f24 36 fields · synced Jun 8, 2026