ArtiFascia®

Basic Information

• Brand Name: ArtiFascia®
• Primary DI: 07290019685012
• Version / Model: 5cm X 5cm (1.96" X 1.96")
• Catalog Number: ART5501
• Company Name: NURAMI MEDICAL LTD
• Labeler DUNS: 600262998
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-14
• Public Version: 1
• Public Version Date: 2024-03-22
• Public Version Status: New
• Public Device Record Key: 0a190a27-9e1e-4b52-8a35-4168e009131f

Device Description

ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia® is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia® readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
GXQ	Dura Substitute	Neurology	882.5910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58044	Dura mater graft, synthetic	A sterile device made from synthetic polymers [e.g., expanded polytetrafluoroethylene (ePTFE), ePTFE/elastic fluoropolymer) intended to be used for the temporary or permanent repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura; it is typically supplied in the form of a patch and may be sutured into place.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019685012	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223445	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5cm X 5cm (1.96 Inches X 1.96 Inches)

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius