Drill Guide Trocar Insert (2.0 mm)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 51839-93Model 51839-45

by Brainlab SE

Identity

Trade Name: Drill Guide Trocar Insert (2.0 mm) EUDAMEDFDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: Drill Guide Tube (4.5 mm) EUDAMED
Model / Reference: 51839-45 EUDAMED
51839-93 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 04056481145057 EUDAMEDFDA UDI
Basic UDI-DI: 4056481DrillGuideTubeCW EUDAMED
Direct Marketing DI: 04056481145057 EUDAMED
510(k) Number: K240701 FDA UDI
FDA Product Code: OLO FDA UDI
EMDN Code: Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Neurological stereotactic surgery system

Drill Guide Trocar Insert (2.0 mm) by Brainlab SE — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Also classified as Neurological stereotactic surgery system.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	4056481DrillGuideTubeCW	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Brainlab SE
EUDAMED SRN: DE-MF-000006183

Sources (2)

EUDAMED 3b699904-dbb2-49e7-998b-2e4837a82423 61 fields · synced Jul 26, 2026
FDA UDI 0abe74c6-882d-4299-9b02-043298c1dfa6 33 fields · synced May 30, 2026