Viper

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: VIPER FDA UDI
Generic Name: Stereotactic surgery system probe, reusable FDA UDI
Device Name: VIPER SYSTEM NAVIGATED JAMSHIDI FOR USE WITH BRAINLAB FDA UDI
Model / Reference: 286701150N FDA UDI
Description: VIPER SYSTEM NAVIGATED JAMSHIDI FOR USE WITH BRAINLAB FDA UDI

Identifiers

Catalog Number: 286701150N FDA UDI
Primary DI / UDI-DI: 10705034388427 FDA UDI
510(k) Number: K120867 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Stereotactic surgery system probe, reusable 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

Category: Stereotactic surgery system probe, reusable

Viper by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Stereotactic surgery system probe, reusable.

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Cleared under the same submission

K120867 also covers:

UNIVERSAL NAVIGATION VIPER — Medos International Sàrl

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: Medos International Sàrl

Sources (1)

FDA UDI d25daa68-b6fd-4fc9-857d-2bf7ba6e24e6 36 fields · synced May 30, 2026