Synicem Shoulder Spacer Trial Case (marked)

Basic Information

• Brand Name: Synicem Shoulder Spacer Trial Case (marked)
• Primary DI: 15060155712717
• Version / Model: 515092
• Catalog Number: 515092
• Company Name: BIOCOMPOSITES LTD
• Labeler DUNS: 424382307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-08
• Public Version: 2
• Public Version Date: 2025-07-16
• Public Version Status: Update
• Public Device Record Key: 3e3af018-9c54-4015-95fa-689d370b9b56

Device Description

Synicem Shoulder Spacer Trial Case (marked)

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63526	Shoulder revision prosthesis trial	A copy of a final shoulder revision prosthesis, in the form of a combined humeral stem and head, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060155712717	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]