ArtiFascia®

FDA UDI

Class II (US FDA UDI)

by Nurami Medical , Ltd.

Identity

Trade Name: ArtiFascia® FDA UDI
Generic Name: Dura mater graft, synthetic FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 5cm X 5cm (1.96" X 1.96") FDA UDI
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. FDA UDI

Identifiers

Catalog Number: ART5501 FDA UDI
Primary DI / UDI-DI: 07290019685012 FDA UDI
510(k) Number: K223445 FDA UDI
FDA Product Code: GXQ FDA UDI
GMDN Term: Dura mater graft, synthetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Dura mater graft, synthetic

ArtiFascia® by Nurami Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dura mater graft, synthetic.

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Cerafix® Dura Substitute — Acera Surgical Inc · Class II
Cerafix® Dura Substitute — Acera Surgical Inc · Class II
NEURO-PATCH — AESCULAP, INC. · Class II
NEURO-PATCH — AESCULAP, INC. · Class II
NEURO-PATCH — AESCULAP, INC. · Class II
Cerafix® Dura Substitute — Acera Surgical Inc · Class II
NEURO-PATCH — AESCULAP, INC. · Class II

Cleared under the same submission

K223445 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Nurami Medical , Ltd.

Sources (1)

FDA UDI 0a190a27-9e1e-4b52-8a35-4168e009131f 38 fields · synced May 30, 2026