Mcrdrv Ø25.4 Hld

FDA UDI

Class II (US FDA UDI)

by Medtech Llc

Identity

Trade Name: MCRDRV Ø25.4 HLD FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: Microdrive Ø25.4mm Holder instrument Rosa Brain 3.0 & One 3.1 Alpha Omega microdrive holder for CRW supplied with2 M5 x 10 wing nut and 1 M4*10 knurled FDA UDI
Model / Reference: 174014 FDA UDI
Description: Microdrive Ø25.4mm Holder instrument Rosa Brain 3.0 & One 3.1 Alpha Omega microdrive holder for CRW supplied with2 M5 x 10 wing nut and 1 M4*10 knurled FDA UDI

Identifiers

Catalog Number: ROSAS00497 FDA UDI
Primary DI / UDI-DI: 03760244032096 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

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

Mcrdrv Ø25.4 Hld by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
Mo¨ller® — MEDTRONIC NAVIGATION, INC. · Class II
StealthStation® S7® — MEDTRONIC NAVIGATION, INC. · Class II
NIM-Spine — MEDTRONIC SOFAMOR DANEK, INC. · Class II
UNIVERSAL NAVIGATION VIPER SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
NAVIGATION ENABLED INSTRUMENTS — MEDOS INTERNATIONAL SARL · Class IIa
Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC. · Class II
Stealth Station® S7™ — MEDTRONIC NAVIGATION, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medtech Llc

Sources (1)

FDA UDI 01aa5309-e4c3-4861-a83f-d1fb347dd0af 35 fields · synced May 30, 2026