FDA device listing
1.3MM X 2.7MM DRILL GUIDE,Ad-Tech Sleeve Guides,DTRAX Spinal System,Facet Screw Insruments,GABBAY-FRATER,Guide…
FDA device listing 1098104025 · Sotera Health LLC
Key facts
| Proprietary names | 1.3MM X 2.7MM DRILL GUIDE,Ad-Tech Sleeve Guides,DTRAX Spinal System,Facet Screw Insruments,GABBAY-FRATER,Guide, surgical, instrument,Guide Wire Insertion Device BowTie,KYPHON® Introducer Tool Kit,LAA Selection Guide,MEDTRONIC Facet Screw Instruments,Needle Guide,P-L VLP UNIV DRILL GDE HANDLE W PVT HD,Prostate Needle Guide,THE SNAKE,TRIPLE DRILL GUIDE,Wire Caddy,Zimmer Guide Pin |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FZX |
| Device names | FZX - Guide, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics Italy SpA, Sterigenics SAS, Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1018470, 1054811, 1061124, 1319639, 1423662, 1526534, 1649518, 1721676, 2029275, 2953359, 3002907620, 3004111573, 3005941719, 3007156625, 3010407203 |
| FEI numbers | 1018470, 1526534, 1721676, 1000114185, 1000138054, 1000306431, 1000512168, 3000215205, 3000215273, 3001236277, 3002807111, 3002907620, 3004111573, 3008133910, 3010407203 |
| Establishment operations | Contract Sterilizer |
| 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