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BCI Sizer Kit

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
BCI Sizer Kit FDA UDI
Generic Name
ENT surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Bone Conduction Implant Template Kit FDA UDI
Model / Reference
51253 FDA UDI
Description
Bone Conduction Implant Template Kit FDA UDI

Identifiers

Primary DI / UDI-DI
09008738512537 FDA UDI
510(k) Number
DEN170009 FDA UDI
FDA Product Code
PFO FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, single-use 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: ENT surgical procedure kit, non-medicated, single-use

BCI Sizer Kit by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT surgical procedure kit, non-medicated, single-use.

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 414b5861-f586-4754-82b4-95bac2a8953f 36 fields · synced May 30, 2026