Hallmark

FDA UDI

Class I (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name: HALLMARK FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Device Name: 14mm Modular Bone Drill FDA UDI
Model / Reference: 62-0034 FDA UDI
Description: 14mm Modular Bone Drill FDA UDI

Identifiers

Primary DI / UDI-DI: 18257200017553 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Manual surgical rotary handpiece, 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

Yes

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

Dimensions & Sizes

Size: Length — 14 Millimeter FDA UDI

Category: Manual surgical rotary handpiece, reusable

Hallmark by Orthofix US LLC — 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: Orthofix US LLC

Sources (1)

FDA UDI 21eb7ee1-ec35-4a19-ace4-3c10e2aa7b81 35 fields · synced May 30, 2026