ArtiFascia® ART5501
GUDID 07290019685012
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.
NURAMI MEDICAL LTD
Dura mater graft, synthetic| Primary Device ID | 07290019685012 |
| NIH Device Record Key | 0a190a27-9e1e-4b52-8a35-4168e009131f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ArtiFascia® |
| Version Model Number | 5cm X 5cm (1.96" X 1.96") |
| Catalog Number | ART5501 |
| Company DUNS | 600262998 |
| Company Name | NURAMI MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com | |
| Phone | (610) 317-1670 |
| support@nurami-medical.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290019685012 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223445
FDA Product Code
| GXQ | Dura Substitute |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-22 |
| Device Publish Date | 2024-03-14 |
On-Brand Devices [ArtiFascia®]
| 07290019685029 | ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFa |
| 07290019685012 | ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFa |
| 07290019685005 | ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFa |
Trademark Results [ArtiFascia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARTIFASCIA 97587126 not registered Live/Pending |
NURAMI MEDICAL Ltd. 2022-09-12 |
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