GLOBAL UNITE™ Short Stem Instrumentation

FDA UDI

Class I (US FDA UDI)

by Symmetry Medical

Identity

Trade Name: GLOBAL UNITE™ Short Stem Instrumentation FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: SHORT PRX HUM BROSTEOTOME 10MM FDA UDI
Model / Reference: 210005110 FDA UDI
Description: SHORT PRX HUM BROSTEOTOME 10MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00847538018554 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic broach 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

GLOBAL UNITE™ Short Stem Instrumentation by Symmetry Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II

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: Symmetry Medical

Sources (1)

FDA UDI 0fa35f29-7d86-4197-957b-64f77b86bb1c 33 fields · synced Jun 8, 2026