Viper System

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 286710118NModel Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery Instruments

by Medos International SARL

Identity

Trade Name: VIPER SYSTEM EUDAMED
VIPER FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Device Name: Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Probes, awls, drivers EUDAMED
VIPER SYSTEM CANNULATED PROBE END CAP FOR USE WITH BRAINLAB FDA UDI
Model / Reference: Universal Navigation Instruments for EXPEDIUM and VIPER MIS Spine Systems - Orthopaedic Surgery Instruments EUDAMED
286710118N EUDAMEDFDA UDI
Description: VIPER SYSTEM CANNULATED PROBE END CAP FOR USE WITH BRAINLAB FDA UDI

Identifiers

Catalog Number: 286710118N FDA UDI
Primary DI / UDI-DI: 10705034388458 EUDAMEDFDA UDI
Basic UDI-DI: 0705034a001505Q EUDAMED
Direct Marketing DI: 10705034388458 EUDAMED
510(k) Number: K120867 FDA UDI
FDA Product Code: OLO FDA UDI
EMDN Code: Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Stereotactic surgery system probe, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Market of Registration: Belgium 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

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

Category: Multi-purpose stereotactic surgery system

Viper System by Medos International Sarl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Also classified as Multi-purpose stereotactic surgery system.

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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	0705034a001505Q	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Medos International SARL
EUDAMED SRN: CH-MF-000014268
Authorised Representative: DePuy Ireland UC IE-AR-000009328

Sources (2)

EUDAMED 26f3fa67-e3a7-4ac7-872a-9f28e0fedee3 61 fields · synced Jul 10, 2026
FDA UDI 24975bb4-8d8a-47af-9111-8a28c58908ec 36 fields · synced May 30, 2026