Diamond Orthopedic

FDA UDI

Class II (US FDA UDI)

by Diamond Orthopedic

Identity

Trade Name: Diamond Orthopedic FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Single-Use Instrumentation Kit, T10 FDA UDI
Model / Reference: DMD-KIT-150T10-S FDA UDI
Description: Single-Use Instrumentation Kit, T10 FDA UDI

Identifiers

Catalog Number: DMD-KIT-150T10-S FDA UDI
Primary DI / UDI-DI: B551DMDKIT150T10S0 FDA UDI
FDA Product Code: HTY FDA UDI
HTW FDA UDI
HXX FDA UDI
HTJ FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.4540 FDA UDI
888.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable Cannulated surgical drill bit, single-use Surgical screwdriver, single-use Surgical depth gauge, single-use

Diamond Orthopedic by Diamond Orthopedic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical depth gauge, single-use.

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DVR® CROSSLOCK EPAK™DEPTH GAUGE — Biomet Orthopedics, Inc. · Class I
FuzeFix Mini — FUSION ORTHOPEDICS, LLC · 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 II	Pending data

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Manufacturer

Manufacturer: Diamond Orthopedic

Sources (1)

FDA UDI 3af2e14d-2d9c-412f-b024-efd9cab8ed3e 35 fields · synced Jun 8, 2026