DuraFuse Dural Clip

Basic Information

• Brand Name: DuraFuse Dural Clip
• Primary DI: 00860007130403
• Version / Model: DC-501
• Company Name: Neuramedica Inc.
• Labeler DUNS: 079885939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-09
• Public Version: 1
• Public Version Date: 2023-03-17
• Public Version Status: New
• Public Device Record Key: 61994351-c46f-47f1-b20d-aebc0f6376b2

Device Description

NeuraMedica Dural Clips are bioabsorbable surgical clips designed to aid in closure of the dura mater in neurosurgical and orthopedic spine procedures. NeuraMedica Dural Clips are 3mm wide by 4.6mm long. They are applied using a reusable stainless steel applier. The NeuraMedica Applier is a separately-supplied reusable instrument.

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: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FZP	Clip, Implantable	General, Plastic Surgery	878.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45413	Ligation clip, synthetic polymer, bioabsorbable	A bioabsorbable clasp intended to be implanted to ligate a vessel (e.g., blood, lymphatic, or other tube-like structure) that does not require permanent occlusion after the surgical procedure, as the device is gradually degraded and digested by body tissues. The device is typically made of a polymer (e.g., polydioxanone), and may be radiolucent; a dedicated, disposable clip applier may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007130403	GS1

Customer Contacts

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