FDA device listing
Pep Introducer Needle
FDA device listing 1697281547 · RHYTHMLINK INTERNATIONAL, LLC
Key facts
| Proprietary names | Pep Introducer Needle |
|---|---|
| Owner/operator | RHYTHMLINK INTERNATIONAL, LLC |
| Owner/operator number | 9052354 |
| Premarket submissions | K103200 |
| Product codes | FMF, MDM |
| Device names | FMF - Syringe, Piston, MDM - Instrument, Manual, Surgical, General Use |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 878.4800, 880.5860 |
| Review panels | General Hospital, General & Plastic Surgery |
| Registered establishments | PINE MOON ELECTRONICS CO., LTD., RHYTHMLINK INTERNATIONAL, LLC |
| Establishment registrations | 1067162, 3006697681 |
| FEI numbers | 3003831320, 3006697681 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler, 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