DuraStat

Basic Information

• Brand Name: DuraStat
• Primary DI: 00850061177117
• Version / Model: DUR-011
• Company Name: Durastat LLC
• Labeler DUNS: 080315253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-04
• Public Version: 1
• Public Version Date: 2026-03-12
• Public Version Status: New
• Public Device Record Key: ce0206de-22d5-49d0-8ac9-c9f70636615a

Device Description

DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency, especially in difficult-to-reach areas. It streamlines the repair process by combining a nerve hook and needle driver into one tool, automating suture passage with a button-press to eliminate supination and minimize tissue disruption. The device features a smooth, curved tip with a pre-loaded 5-0 PTFE suture and needle, allowing for precise, consistent placement and watertight closure to prevent persistent cerebrospinal fluid (CSF) leaks.

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: No
• PM Exempt: No
• 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
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	878.5035	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13909	Polyolefin/fluoropolymer suture, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850061177117	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173335	000