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Drive Rail System

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
Drive Rail System FDA UDI
Generic Name
Surgical instrument handle, torque-limiting FDA UDI
Device Name
TORQUE T-HANDLE FDA UDI
Model / Reference
29-0018 FDA UDI
Description
TORQUE T-HANDLE FDA UDI

Identifiers

Catalog Number
29-0018 FDA UDI
Primary DI / UDI-DI
00817867020771 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical instrument handle, torque-limiting 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument handle, torque-limiting

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

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 221d546f-9603-4c6b-9abe-ee7c97c00c0b 35 fields · synced Jun 8, 2026