FDA device listing
MEDLINE CATHETER, RETENTION TYPE, BALLOON - EZL,MEDLINE SILVERTOUCH FOLEY CATHETER
FDA device listing 1076931917 · Medline Industries, LP
Key facts
| Proprietary names | MEDLINE CATHETER, RETENTION TYPE, BALLOON - EZL,MEDLINE SILVERTOUCH FOLEY CATHETER |
|---|---|
| Owner/operator | Medline Industries, LP |
| Owner/operator number | 1417592 |
| Premarket submissions | K052168 |
| Product codes | EZL |
| Device names | EZL - Catheter, Retention Type, Balloon |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5130 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Medline Industries, LP - Mexicali (MXC), MEDLINE INDUSTRIES, LP - Northfield |
| Establishment registrations | 1417592, 3015173212 |
| FEI numbers | 1417592, 3015173212 |
| Establishment operations | Contract Sterilizer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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