Reunion

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: REUNION FDA UDI
Generic Name: Glenoid orthopaedic reamer FDA UDI
Device Name: Humeral Reamer (15mm) FDA UDI
Model / Reference: 5901-4015 FDA UDI
Description: Humeral Reamer (15mm) FDA UDI

Identifiers

Catalog Number: 5901-4015 FDA UDI
Primary DI / UDI-DI: 07613327424751 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Glenoid orthopaedic reamer 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

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Glenoid orthopaedic reamer

A high-quality humeral reamer designed for precision cutting and resurfacing of the glenoid fossa in orthopedic surgical procedures. The device is made from a durable, high-grade stainless steel alloy and features a hemispherical head with an abrasive/cutting outer surface attached to a shaft.

Similar devices

Also classified as Glenoid orthopaedic reamer.

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LINK Embrace Shoulder System Line Extension — WALDEMAR LINK GmbH & Co. KG · Class I
Alliance — Zimmer, Inc. · Class II
PRIMA TT Glenoid — Limacorporate · Class II
OFF AXIS COMP MINI REAMER 6-SPOKE LG — Biomet Orthopedics, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
Equinoxe — Exactech, Inc. · 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: Stryker Corp.

Sources (1)

FDA UDI 481d8596-6089-491b-a5c7-2e1e61f16b94 34 fields · synced Jul 25, 2026