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Cochlear Baha Telecoil

FDA UDI

Class II (US FDA UDI)

by Cochlear

Identity

Trade Name
Cochlear Baha Telecoil FDA UDI
Generic Name
Bone-conduction hearing implant system sound processor/vibrator FDA UDI
Device Name
N/A FDA UDI
Model / Reference
91181 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
91181 FDA UDI
Primary DI / UDI-DI
09321502016568 FDA UDI
510(k) Number
K955713 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Bone-conduction hearing implant system sound processor/vibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Cochlear Baha Telecoil by Cochlear — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K955713 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear

Sources (1)

  • FDA UDI 493c1610-5644-43e3-a7e3-9c683163073f 37 fields · synced May 31, 2026