CERAMENT™|BEAD TRAY

Basic Information

• Brand Name: CERAMENT™|BEAD TRAY
• Primary DI: 07350055430318
• Version / Model: A0513
• Company Name: Bone Support AB
• Labeler DUNS: 350066052
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-07
• Public Version: 1
• Public Version Date: 2023-06-15
• Public Version Status: New
• Public Device Record Key: 1b631ba6-700d-4609-8c42-bac4365a6661

Device Description

A single use bead mold for molding beads out of ceramic bone graft substitutes. The bead mold consists of cavities in three different sizes. The cavities are filled with ceramic bone graft substitute and evenly distributed across the mold using the spatula. The ceramic bone graft substitute sets in the cavities and the ceramic bone graft substitute beads are then removed from the mold.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
66750	Synthetic bone graft bead mould	A device typically in the form of a tray with rows of rounded depressions of various sizes intended to mould synthetic (e.g., ceramic) bone grafts into beads (small spherical-like portions) for subsequent placement into a bone void. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350055430318	GS1