FDA device listing
[AT-310-24] Kolle Micro NH With Plastic Handle 24 cm - 9 1/2 SS,[RH-271-15] Cottle Masing Needle Holder Smooth Jaws…
FDA device listing 1069949336 · Surtex Instruments Ltd
Key facts
| Proprietary names | [AT-310-24] Kolle Micro NH With Plastic Handle 24 cm - 9 1/2 SS,[RH-271-15] Cottle Masing Needle Holder Smooth Jaws Shaft Size 15 cm - 6 Stainless Steel,[SU-010-12] Derf Needle Holder One Fenestrated Jaw 12 cm - 4 3/4 Stainless Steel,[SU-012-12] Converse Needle Holder Jaws With Longitudinal Serrations 13 cm - 5 Stainless Steel,[SU-016-12] Collier Needle Holder Grooved Jaws 12.5 cm - 5 Stainless… |
|---|---|
| Owner/operator | Surtex Instruments Ltd |
| Owner/operator number | 10061887 |
| Product codes | FHQ |
| Device names | FHQ - Holder, Needle, Gastroenterologic |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.4730 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | SURTEX INSTRUMENTS LTD |
| Establishment registrations | 3016069968 |
| FEI numbers | 3016069968 |
| Establishment operations | Manufacturer, Remanufacturer, 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