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HiRes 90K™ CI HiFocus™ 1j Electrode

FDA UDI

Class III (US FDA UDI)

by Advanced Bionics

Identity

Trade Name
HiRes 90K™ CI HiFocus™ 1j Electrode FDA UDI
Generic Name
Cochlear implant system electrode array assembly FDA UDI
Model / Reference
CI-1400-01 FDA UDI

Identifiers

Primary DI / UDI-DI
07630016816253 FDA UDI
PMA Number
P960058 FDA UDI
FDA Product Code
MCM FDA UDI
GMDN Term
Cochlear implant system electrode array assembly FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

HiRes 90K™ CI HiFocus™ 1j Electrode by Advanced Bionics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P960058 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Advanced Bionics

Sources (1)

  • FDA UDI 56a70216-d517-4c1c-850c-05b0e3824eb9 36 fields · synced May 31, 2026