FDA device listing
Aquablation Therapy,Convenience Trays & Kits CSTM,Medline / Eclipse / Aurora / Sirus surgical packs,MEDLINE General…
FDA device listing 1334665172 · Medline Industries, LP
Key facts
| Proprietary names | Aquablation Therapy,Convenience Trays & Kits CSTM,Medline / Eclipse / Aurora / Sirus surgical packs,MEDLINE General surgery tray (kit),Medline Proxima,Medline surgical kits/trays and CDS modules,Procept |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | LRO |
| Device names | LRO - General Surgery Tray |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4370 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Medline Canada, MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, MEDLINE INDUSTRIES, LP (Northpoint Services), MEDLINE INDUSTRIES, LP - SPT, Medline Panama LLC S. de R.L., Medline Soluciones Medicas, Microtek Dominicana, S.A.S., MICROTEK DOMINICANA, S.A.S., Microtek Medical LLC, Nuevo Laredo Directo al Cliente and 1 more |
| Establishment registrations | 1417592, 1422634, 1423395, 8043817, 3004122598, 3005595283, 3007289408, 3012811961, 3014342658, 3015173212, 3016761372, 3045816902, 3045816907 |
| FEI numbers | 1417592, 1000514656, 3000717925, 3003094575, 3004122598, 3005595283, 3007289408, 3012811961, 3014342658, 3015173212, 3016761372, 3045816902, 3045816907 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 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