Reunion

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: REUNION FDA UDI
Generic Name: Glenoid orthopaedic reamer FDA UDI
Device Name: RSA Half-Moon Reamer/Planar Size 40 FDA UDI
Model / Reference: 5901-6097 FDA UDI
Description: RSA Half-Moon Reamer/Planar Size 40 FDA UDI

Identifiers

Catalog Number: 5901-6097 FDA UDI
Primary DI / UDI-DI: 07613327418705 FDA UDI
FDA Product Code: KWS FDA UDI
HSD FDA UDI
PHX FDA UDI
GMDN Term: Glenoid orthopaedic reamer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3690 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

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

Category: Glenoid orthopaedic reamer

Reunion by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI 8d3c8fcf-7ed1-46e5-98b2-29b11f2af408 34 fields · synced Jun 8, 2026