FDA device listing
TIP, CARBIDE DRILL BIT, 2MM, Single Use,TIP, CARBIDE DRILL BIT, 3MM, Single Use,TIP, CARBIDE DRILL BIT, 4MM, Single…
FDA device listing 1159899478 · S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
Key facts
| Proprietary names | TIP, CARBIDE DRILL BIT, 2MM, Single Use,TIP, CARBIDE DRILL BIT, 3MM, Single Use,TIP, CARBIDE DRILL BIT, 4MM, Single Use,TIP, CARBIDE DRILL BIT, 5MM, Single Use,TIP, CARBIDE DRILL BIT, 6MM, Single Use,TIP, CARBIDE DRILL BIT, 7MM, Single Use |
|---|---|
| Owner/operator | S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL |
| Owner/operator number | 9035854 |
| Product codes | HTW |
| Device names | HTW - Bit, Drill |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL, S. S. White Technologies India Pvt. Ltd. |
| Establishment registrations | 2249418, 3011365613 |
| FEI numbers | 2183899, 3011365613 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer |
| 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