OsteoPoint

Basic Information

• Brand Name: OsteoPoint
• Primary DI: 04260647240382
• Version / Model: HCT-BC-16
• Company Name: Morpheus AG
• Labeler DUNS: 315142027
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-26
• Public Version: 1
• Public Version Date: 2024-12-04
• Public Version Status: New
• Public Device Record Key: 3b80410f-5b7d-49f1-8d63-eeb3a08af66c

Device Description

HC Biologics OsteoPoint Bone & Tissue Trap

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
BYZ	Trap, Sterile Specimen	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17131	Orthopaedic surgery tissue debris collector, single-use	A container designed to collect bone, cartilage, or adjacent soft-tissue debris/fragments (e.g., extracted by shaving or drilling procedures) during orthopaedic surgery (e.g., autograft transplantation). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260647240382	GS1