FDA device listing
D.A.L.K. Spatula Dissection Set,Disposable Eckardt Membrane Pic,Disposable ILM Micro Pick Needle,Disposable…
FDA device listing 1407185160 · D.O.R.C. Dutch Ophthalmic Research Center (International) B.
Key facts
| Proprietary names | D.A.L.K. Spatula Dissection Set,Disposable Eckardt Membrane Pic,Disposable ILM Micro Pick Needle,Disposable Microscissors: Hooked,Disposable reversed Sinskey hook with irrigation,DMEK Sinskey Hook Down,Eckardt Membrane Pic,Extendible curved spatula,P.L.K. Scraper |
|---|---|
| Owner/operator | D.O.R.C. Dutch Ophthalmic Research Center (International) B. |
| Owner/operator number | 8030460 |
| Product codes | HND |
| Device names | HND - Spatula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. |
| Establishment registrations | 9611516 |
| FEI numbers | 3002806863 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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