Hex Screwdriver Ball-End (2.5 Mm)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 55758-30

by Brainlab SE

Identity

Trade Name: HEX SCREWDRIVER BALL-END (2.5 MM) EUDAMED
Hex Screwdriver Ball-End (2.5 MM) FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: HEX SCREWDRIVER BALL-END (2.5 MM) EUDAMED
Model / Reference: 55758-30 EUDAMEDFDA UDI

Identifiers

Catalog Number: 55758-30 FDA UDI
Primary DI / UDI-DI: 04056481139285 EUDAMEDFDA UDI
Basic UDI-DI: 4056481ScrewdriverGD EUDAMED
Direct Marketing DI: 04056481139285 EUDAMED
FDA Product Code: GXL FDA UDI
HXC FDA UDI
EMDN Code: Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 882.4900 FDA UDI
888.4540 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

Yes

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: Multi-purpose stereotactic surgery system

Hex Screwdriver Ball-End (2.5 Mm) by Brainlab SE — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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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	4056481ScrewdriverGD	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 d6c48abf-f769-4a42-9e1e-71d9abc32a6f 61 fields · synced Jul 9, 2026
FDA UDI 7ac57109-acdb-436a-accc-1cfa71684bd3 34 fields · synced May 30, 2026