MEDENTiKA

FDA UDI

Class I (US FDA UDI)

by Medentika GmbH

Identity

Trade Name: MEDENTiKA FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: Cortical drill FDA UDI
Model / Reference: 5-14-04 FDA UDI
Description: Cortical drill FDA UDI

Identifiers

Catalog Number: 5-14-04 FDA UDI
Primary DI / UDI-DI: 04251574841469 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Fluted surgical drill bit, reusable

MEDENTiKA by Medentika GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Medentika GmbH

Sources (1)

FDA UDI 9a4aeff2-a659-4f76-8e64-9aa71378a5c6 36 fields · synced May 31, 2026