Orientation Guide

FDA UDI

Class I (US FDA UDI)

by Si-Bone Inc.

Identity

Trade Name: Orientation Guide FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: Orientation Guide FDA UDI
Model / Reference: 501824 FDA UDI
Description: Orientation Guide FDA UDI

Identifiers

Primary DI / UDI-DI: 00810055522828 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

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

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic implantation sleeve, reusable

Orientation Guide by Si-Bone Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Jet-X — Smith & Nephew, Inc. · Class II
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Salvo® Spine System — Spine Wave, Inc. · Class I
DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Si-Bone Inc.

Sources (1)

FDA UDI 52413e3b-ff30-4b52-a058-7b87376a58ec 34 fields · synced May 30, 2026