FDA device listing
NovoSorb® BTM,NovoSorb® SynPath™
FDA device listing 1348212028 · PolyNovo Biomaterials Pty Ltd
Key facts
| Proprietary names | NovoSorb® BTM,NovoSorb® SynPath™ |
|---|---|
| Owner/operator | PolyNovo Biomaterials Pty Ltd |
| Owner/operator number | 10046720 |
| Premarket submissions | K251567 |
| Product codes | QSZ |
| Device names | QSZ - Absorbable Synthetic Wound Dressing |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.QSZ |
| Review panels | General & Plastic Surgery |
| Registered establishments | POLYNOVO BIOMATERIALS PTY LTD |
| Establishment registrations | 3007886187 |
| FEI numbers | 3007886187 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database