OsteoPoint

Basic Information

• Brand Name: OsteoPoint
• Primary DI: 04260647240344
• Version / Model: HCT-04-160
• 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: ae0d779d-252f-4619-83be-da0cc9b728b1

Device Description

HC Biologics OsteoPoint Bone Removal System 4mm x 160mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAE	Rongeur, Manual	Neurology	882.4840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32853	Orthopaedic joint/limb rongeur	A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260647240344	GS1