PointerShell Universal

FDA UDI

Class II (US FDA UDI)

by Fiagon GmbH

Identity

Trade Name: PointerShell Universal FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5mm. The device is accessory to the Cube 4D Navigation system. FDA UDI
Model / Reference: E012904 FDA UDI
Description: The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5mm. The device is accessory to the Cube 4D Navigation system. FDA UDI

Identifiers

Catalog Number: E012904 FDA UDI
Primary DI / UDI-DI: 04260759930393 FDA UDI
510(k) Number: K160479 FDA UDI
FDA Product Code: PGW 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

MRI Safety

MR Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

PointerShell Universal by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose stereotactic surgery system.

PEEK INSTRUMENT ADAPTOR Ø2.15MM — MEDTECH LLC · Class II
TRIALTIS Spine System — MEDOS INTERNATIONAL SARL · Class IIa
PEEK INSTRUMENT ADAPTOR Ø4.6MM — MEDTECH LLC · Class II
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

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: Fiagon GmbH

Sources (1)

FDA UDI aa73ffd5-55c7-4852-9457-10f0c2ee1da1 36 fields · synced May 30, 2026