FDA device listing
Breast 7 Biopsy Pack, 1.5T,Kit, Enhanced Access, Bilateral Upgrade,Sentinelle, Biopsy Grid
FDA device listing 1885209448 · Philips Medical Systems International BV
Key facts
| Proprietary names | Breast 7 Biopsy Pack, 1.5T,Kit, Enhanced Access, Bilateral Upgrade,Sentinelle, Biopsy Grid |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Product codes | PXP |
| Device names | PXP - Breast Biopsy / Localization Tray |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Philips Global Business Services LLP, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Establishment registrations | 3016851825, 3042177665 |
| FEI numbers | 3016851825, 3042177665 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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