FDA device listing
Biotronix Healthcare Abdominal Pads ABD,Biotronix Healthcare Adhesive Elastic Bandages,Biotronix Healthcare Conforming…
FDA device listing 1363774392 · Biotronix Healthcare Industries Inc.
Key facts
| Proprietary names | Biotronix Healthcare Abdominal Pads ABD,Biotronix Healthcare Adhesive Elastic Bandages,Biotronix Healthcare Conforming Gauze Bandages N/S,Biotronix Healthcare Conforming Gauze Bandages Sterile,Biotronix Healthcare Gauze Rolls 36 x 100yds 19x15, N/S,Biotronix Healthcare Gauze Rolls 36 x 100yds 19x15, X-Ray Detectable, N/S,Biotronix Healthcare Gauze Rolls 36 x 100yds 20x12, N/S,Biotronix Healthcare… |
|---|---|
| Owner/operator | Biotronix Healthcare Industries Inc. |
| Owner/operator number | 10043487 |
| Product codes | NAB |
| Device names | NAB - Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4014 |
| Review panels | General & Plastic Surgery |
| Registered establishments | BIOTRONIX HEALTHCARE INDUSTRIES INC. |
| Establishment registrations | 3010131137 |
| FEI numbers | 3010131137 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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