Leksell Frame Registration Plates

FDA UDI

Class II (US FDA UDI)

by Medtech Llc

Identity

Trade Name: LEKSELL FRAME REGISTRATION PLATES FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: LEKSELL FRAME REGISTRATION PLATES instrument Rosa 3.0 instrument Rosa 3.1 Leksell frame regsitration plates : calibrated tool for manual regsitration of the device with the leksell frame. Mounted on the leksell stereotactic frame. FDA UDI
Model / Reference: ROSA3-286A FDA UDI
Description: LEKSELL FRAME REGISTRATION PLATES instrument Rosa 3.0 instrument Rosa 3.1 Leksell frame regsitration plates : calibrated tool for manual regsitration of the device with the leksell frame. Mounted on the leksell stereotactic frame. FDA UDI

Identifiers

Catalog Number: ROSAS00347 FDA UDI
Primary DI / UDI-DI: 03760244031389 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Multi-purpose 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Neurological stereotactic surgery system Multi-purpose stereotactic surgery system

Leksell Frame Registration Plates by Medtech Llc — 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: Medtech Llc

Sources (1)

FDA UDI 0cf5d9d5-46de-4770-9d9a-71f1ffeb9d40 34 fields · synced May 30, 2026