Ortho Solutions Ultos/Volition Plating System

FDA UDI

Class I (US FDA UDI)

by Ortho Solutions Holdings Limited

Identity

Trade Name: ORTHO SOLUTIONS ULTOS/VOLITION PLATING SYSTEM FDA UDI
Generic Name: Surgical depth gauge, reusable FDA UDI
Device Name: UltOS/VOLITION DEPTH GAUGE FDA UDI
Model / Reference: OS328001-NS FDA UDI
Description: UltOS/VOLITION DEPTH GAUGE FDA UDI

Identifiers

Catalog Number: OS328001-NS FDA UDI
Primary DI / UDI-DI: 05055662968392 FDA UDI
FDA Product Code: HTJ FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4300 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

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: Surgical depth gauge, reusable

Ortho Solutions Ultos/Volition Plating System by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · 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: Ortho Solutions Holdings Limited

Sources (1)

FDA UDI 907abe5a-766e-44d6-8742-c9de5c41b3af 35 fields · synced May 31, 2026