DuraStat

GUDID 00850061177001

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.

Durastat LLC

Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 00850061177001
• NIH Device Record Key: 98d4a208-b46c-49b6-88eb-67277c9228b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraStat
• Version Model Number: GZL-002
• Company DUNS: 080315253
• Company Name: Durastat LLC
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM
• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM
• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM
• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM
• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM
• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM
• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM
• Phone: 18008048018
• Email: CUSTOMERSERVICE@DURASTAT.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850061177001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173335

FDA Product Code

• NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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: 2026-03-12
• Device Publish Date: 2026-03-04

On-Brand Devices [DuraStat]

• B532GZL0020: DuraStat is indicated for use in general soft tissue approximation and/or ligation, including: c
• 00850061177117: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling
• 00850061177032: 10-CT INNER PACK: DuraStat is a surgical device designed for dural repair in spine and cranial s
• 00850061177018: 10-CT CASE: DuraStat is a surgical device designed for dural repair in spine and cranial surgeri
• 00850061177001: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling