MEDENTiKA

FDA UDI

Class I (US FDA UDI)

by Medentika GmbH

Identity

Trade Name: MEDENTiKA FDA UDI
Generic Name: Surgical drill guide, single-use FDA UDI
Device Name: MedentiGuide Inner sleeve FDA UDI
Model / Reference: 0-32-23 FDA UDI
Description: MedentiGuide Inner sleeve FDA UDI

Identifiers

Catalog Number: 0-32-23 FDA UDI
Primary DI / UDI-DI: EMKA032239 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical drill guide, single-use 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

Yes

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 Conditional FDA UDI

Category: Surgical drill guide, single-use

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 e964f0bf-62c6-4397-a5b0-868fc6d68357 36 fields · synced Jun 8, 2026