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: 3cm X 4cm (1.18" X 1.57") 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: ART3401 FDA UDI
Primary DI / UDI-DI: 07290019685005 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.

NEURO-PATCH — AESCULAP, INC. · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nurami Medical , Ltd.

Sources (1)

FDA UDI 8f2aa342-ff94-48f7-b4a4-828c1f8ee52a 38 fields · synced May 30, 2026