Leksell Stereotactic System

FDA UDI

Class II (US FDA UDI)

by Elekta Instrument AB

Identity

Trade Name: Leksell Stereotactic System FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Device Name: QUICK FIXATION SCREW L=80 MM FDA UDI
Model / Reference: 13012710 FDA UDI
Description: QUICK FIXATION SCREW L=80 MM FDA UDI

Identifiers

Primary DI / UDI-DI: 07340048302463 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Neurological stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 80.0 Millimeter FDA UDI

Category: Neurological stereotactic surgery system

Leksell Stereotactic System by Elekta Instrument AB — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Elekta Instrument AB

Sources (1)

FDA UDI 5b447503-b487-47e9-8445-0ba55cfd902f 35 fields · synced Jun 1, 2026