FDA device listing
ACCU-SORB,Accu-Wrap,Bandages,CoFlex,CoFlex LF2,CURAD,Esmark,Fourflex,Matrix,Medline Elastic Bandage,Medline Elastic…
FDA device listing 1704204612 · Medline Industries, LP
Key facts
| Proprietary names | ACCU-SORB,Accu-Wrap,Bandages,CoFlex,CoFlex LF2,CURAD,Esmark,Fourflex,Matrix,Medline Elastic Bandage,Medline Elastic Retention Netting,Medline Stockinette,Microtek,Sure-Wrap Elastic Bandage,Threeflex,TwoFlex,Unna,Unna-Z |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Product codes | FQM |
| Device names | FQM - Bandage, Elastic |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5075 |
| Review panels | General Hospital |
| Registered establishments | Medline Canada, MEDLINE INDUSTRIES, LP - Laredo, Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield, Medline Soluciones Medicas, MICROTEK DOMINICANA, S.A.S., Microtek Medical LLC, Nuevo Laredo Directo al Cliente, PRODUCTOS MEDLINE S.A. DE C.V. |
| Establishment registrations | 1417592, 8043817, 3004122598, 3005595283, 3007289408, 3013401749, 3014342658, 3015173212, 3021970868, 3045816902, 3045816907 |
| FEI numbers | 1417592, 3003094575, 3004122598, 3005595283, 3007289408, 3013401749, 3014342658, 3015173212, 3021970868, 3045816902, 3045816907 |
| Establishment operations | Complaint File Establishment, Specification Developer, Contract Sterilizer, Manufacturer, Repackager/Relabeler, Foreign Exporter |
| 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