10-CT INNER PACK: DuraStat is a surgical device designed for dural repair in spine and cranial surgeries, enabling higher-quality, gold standard sutured closures with greater efficiency,…
10-CT INNER PACK: 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.
Who Else Makes It
Registered in Shandong.
Record
Regulatory record for DuraStat | Listed by | DuraStat, United States |
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K173335 |
| Record published | 2026-03-04 |
| Record revised | 2024-09-30 (version 4) |
Specifications
Specifications | MRI safety | MR Safe |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.