FDA device listing
459801507722 Biopsy Grid, Sterilized [Pouch],459801813442 Sentinelle, Biopsy Grid [Pouch],989603203454 MRI Needle Block…
FDA device listing 1424578412 · Sotera Health LLC
Key facts
| Proprietary names | 459801507722 Biopsy Grid, Sterilized [Pouch],459801813442 Sentinelle, Biopsy Grid [Pouch],989603203454 MRI Needle Block 8G,989603203464 MRI Needle Block 12G,989603203474 MRI Needle Block 14G,989603203484 MRI Needle Block 18G,989603203494MRI Needle Sleeve 12G,989603203504 MRI Needle Sleeve 14G,989603203514 MRI Needle Sleeve 18G,989603203524 Grid Immobilization Plate,989603203534 Pillar… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GDF |
| Device names | GDF - Guide, Needle, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1054811, 1061124, 2029275, 2953359, 3004111573 |
| FEI numbers | 1000114185, 1000306431, 1000512168, 3000215205, 3004111573 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 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