DEVICE: ArtiFascia® (07290019685005)

Device Identifier (DI) Information

ArtiFascia®
3cm X 4cm (1.18" X 1.57")
In Commercial Distribution
ART3401
NURAMI MEDICAL LTD
07290019685005
GS1

1
600262998 *Terms of Use
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.
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Device Characteristics

MR Safe
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
GXQ Dura Substitute
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K223445 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 3cm X 4cm (1.18 Inches X 1.57 Inches)
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Device Record Status

8f2aa342-ff94-48f7-b4a4-828c1f8ee52a
March 22, 2024
1
March 14, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
(610) 317-1670
support@nurami-medical.com
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