Cruciform Driver

FDA UDI

Class I (US FDA UDI)

by Toby Orthopaedics

Identity

Trade Name: Cruciform Driver FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver assembly handles are made from machined Radel. FDA UDI
Model / Reference: NA FDA UDI
Description: Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver assembly handles are made from machined Radel. FDA UDI

Identifiers

Catalog Number: TO-DRI-CR FDA UDI
Primary DI / UDI-DI: 00816101010325 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Surgical screwdriver, 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

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 screwdriver, reusable

Cruciform Driver by Toby Orthopaedics — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Toby Orthopaedics

Sources (1)

FDA UDI 95814daf-e608-437e-a52a-7b0018f5928b 35 fields · synced Jun 1, 2026