REUNION

Basic Information

• Brand Name: REUNION
• Primary DI: 07613327516265
• Version / Model: 5570-4002
• Catalog Number: 5570-4002
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-05
• Public Version: 1
• Public Version Date: 2021-02-15
• Public Version Status: New
• Public Device Record Key: 184b51b5-1f29-44b0-b3d0-78ec5a3c4473

Device Description

Humeral Cup

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60514	Metallic reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a metal cup intended to be attached to either a humeral stem prosthesis or humeral body component, and to articulate with the reverse shoulder head.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327516265	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Thickness: 2.0 Millimeter
Device Size Text, specify			Diameter: 40.0 Millimeter