Drive Rail System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name: Drive Rail System FDA UDI
Generic Name: Surgical torque wrench, reusable FDA UDI
Device Name: 10 mm Ratchet Wrench FDA UDI
Model / Reference: 29-0020 FDA UDI
Description: 10 mm Ratchet Wrench FDA UDI

Identifiers

Catalog Number: 29-0020 FDA UDI
Primary DI / UDI-DI: 00817867020795 FDA UDI
FDA Product Code: HXC FDA UDI
GMDN Term: Surgical torque wrench, 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

Category: Surgical torque wrench, reusable

Drive Rail System by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical torque wrench, reusable.

XIA 3 — Stryker Corp. · Class I
Momentum — ULRICH MEDICAL USA, INC. · Class II
Mariner Deformity — SeaSpine Orthopedics Corporation · Class I
Zavation — ZAVATION · Class II
IMHS — Smith & Nephew, Inc. · Class II
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED · Class II
X FIX — Biomet Orthopedics, Inc. · Class I
BIONNOVATION — BIONNOVATION PRODUTOS BIOMEDICOS LTDA. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Orthopediatrics Corp.

Sources (1)

FDA UDI daf0b94d-f2ad-4ea3-80c6-57f57216d40a 35 fields · synced May 30, 2026