FDA device listing
TF1000I - Tenderfoot Newborn Heel Incision Device,TF200I - Tenderfoot Newborn Heel Incision Device,TF50I - Tenderfoot…
FDA device listing 1233397044 · Instrumentation Laboratory SpA
Key facts
| Proprietary names | TF1000I - Tenderfoot Newborn Heel Incision Device,TF200I - Tenderfoot Newborn Heel Incision Device,TF50I - Tenderfoot Newborn Heel Incision Device,TFM50I - Tenderfoot Micro-Preemie Heel Incision Device,TFP1000I - Tenderfoot Preemie Heel Incision Device,TFP200I - Tenderfoot Preemie Heel Incision Device,TFP50I - Tenderfoot Preemie Heel Incision Device,TFT50I - Tenderfoot Toddler Heel Incision Device |
|---|---|
| Owner/operator | Instrumentation Laboratory SpA |
| Owner/operator number | 10082968 |
| Premarket submissions | K223352 |
| Product codes | FMK |
| Device names | FMK - Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4850 |
| Review panels | General & Plastic Surgery |
| Registered establishments | INSTRUMENTATION LABORATORY SPA |
| Establishment registrations | 3012348571 |
| FEI numbers | 3012348571 |
| Establishment operations | Foreign Exporter |
| 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