SIros Navigated Instruments

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name: SIros Navigated Instruments FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: 9.5mm SI Navigated Large Bore Drill FDA UDI
Model / Reference: 1 FDA UDI
Description: 9.5mm SI Navigated Large Bore Drill FDA UDI

Identifiers

Catalog Number: GSI246-095 FDA UDI
Primary DI / UDI-DI: M719GSI2460950 FDA UDI
FDA Product Code: OUR FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

Dimensions & Sizes

Size: Outer Diameter — 9.5 Millimeter FDA UDI

Category: Fluted surgical drill bit, reusable

SIros Navigated Instruments by Genesys Orthopedics Systems 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: Genesys Orthopedics Systems LLC

Sources (1)

FDA UDI 9e76f2c2-b4af-43fe-b527-1771e58fcc5a 36 fields · synced Jun 1, 2026