VersaPEEK Tapping Tool

FDA UDI

Class I (US FDA UDI)

by Ortho-Design (pty) Ltd

Identity

Trade Name: VersaPEEK Tapping Tool FDA UDI
Generic Name: Orthopaedic bone screw starter/notcher FDA UDI
Device Name: VersaPEEK™, Anchor Tapping Tool, 5mm, AO Coupling FDA UDI
Model / Reference: APP001-2 FDA UDI
Description: VersaPEEK™, Anchor Tapping Tool, 5mm, AO Coupling FDA UDI

Identifiers

Catalog Number: APP001-2 FDA UDI
Primary DI / UDI-DI: 06009712642892 FDA UDI
FDA Product Code: HWX FDA UDI
GMDN Term: Orthopaedic bone screw starter/notcher 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw starter/notcher

VersaPEEK Tapping Tool by Ortho-Design (pty) Ltd — 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: Ortho-Design (pty) Ltd

Sources (1)

FDA UDI 179597f5-3f64-48ef-be30-530ea1f2da66 35 fields · synced May 30, 2026