OSSDSIGN Cranial PSI

Basic Information

• Brand Name: OSSDSIGN Cranial PSI
• Primary DI: 07350086550085
• Version / Model: S
• Company Name: Ossdsign AB
• Labeler DUNS: 350354370
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-11
• Public Version: 4
• Public Version Date: 2024-02-06
• Public Version Status: Update
• Public Device Record Key: 484c4349-9232-4913-90c3-90107fbf1f12
• Distribution End Date: 2023-11-30

Device Description

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46268	Cranioplasty plate, non-alterable	An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350086550085	GS1
Package	17350086550082	GS1	Box	1	Not in Commercial Distribution	2023-11-30

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 34 Degrees Celsius