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BCI Bone Conduction Implant Kit

FDA UDI

Class II (US FDA UDI)

by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Identity

Trade Name
BCI Bone Conduction Implant Kit FDA UDI
Generic Name
Implantable vibrator bone-conduction hearing implant system FDA UDI
Device Name
Bone Conduction Implant Kit FDA UDI
Model / Reference
52180 FDA UDI
Description
Bone Conduction Implant Kit FDA UDI

Identifiers

Primary DI / UDI-DI
09008738521805 FDA UDI
510(k) Number
DEN170009 FDA UDI
FDA Product Code
PFO FDA UDI
GMDN Term
Implantable vibrator bone-conduction hearing implant system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3340 FDA UDI
Commercial Distribution
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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Implantable vibrator bone-conduction hearing implant system

BCI Bone Conduction Implant Kit by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Implantable vibrator bone-conduction hearing implant system.

Cleared under the same submission

DEN170009 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Sources (1)

  • FDA UDI e1882ef1-66f6-4c05-bc53-5ea80c0ed006 36 fields · synced May 31, 2026