Identity
- Trade Name
- Helix Cochleostomy Sizing Gauge FDA UDI
- Generic Name
- Cochlear implant system FDA UDI
- Model / Reference
- CI-4345 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630016809958 FDA UDI
- PMA Number
- P960058 FDA UDI
- FDA Product Code
- MCM FDA UDI
- GMDN Term
- Cochlear implant system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Helix Cochleostomy Sizing Gauge by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P960058 also covers:
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- Chorus™ Sound Processor — Advanced Bionics
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- HiRes™ Ultra Recess Gauge — Advanced Bionics
- M Battery — Advanced Bionics
- M Standard Battery — Advanced Bionics
- M Zn-Air Battery Pak — Advanced Bionics
- MRI Antenna Coil Cover — Advanced Bionics
- Naida CI Q90 — Advanced Bionics
- Naida™ CI M30 — Advanced Bionics
- Naida™ CI M90 Sound Processor — Advanced Bionics
- Neptune™ Cable for AquaMic™ — Advanced Bionics
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
- Advanced Bionics
Sources (1)
- FDA UDI acde7031-b44d-4a16-9118-79edf4f7dfc3 35 fields · synced Jun 1, 2026