FDA device listing
GLOBAL BONE EXPANDER KIT,INSTRUMENTS TRAY FOR,INSTRUMENT TRAY ECHOPLAN,KIT D.B.E. SYSTEM,M.I.S.E. EVO KIT,OUTLINK2…
FDA device listing 1561715752 · Sweden & Martina INC
Key facts
| Proprietary names | GLOBAL BONE EXPANDER KIT,INSTRUMENTS TRAY FOR,INSTRUMENT TRAY ECHOPLAN,KIT D.B.E. SYSTEM,M.I.S.E. EVO KIT,OUTLINK2 SUPPLEMENTARY INSTR.,PREMIUM SUPPLEMENTARY INSTR.,PROSTHETIC ACCESSORIES KIT,REMOVAL SCREW KIT,SURGICAL KIT,SURGICAL KIT ECHOPLAN,SURGICAL KIT ECHOPLAN PRO,SURGICAL KIT "ONEBOX",SURGICAL KIT "ONEBOX2",SURG. KIT FOR PREMIUM-SHELTA |
|---|---|
| Owner/operator | Sweden & Martina INC |
| Owner/operator number | 10048147 |
| Premarket submissions | K222640 |
| Product codes | KCT |
| Device names | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6850 |
| Review panels | General Hospital |
| Registered establishments | SWEDEN & MARTINA INC |
| Establishment registrations | 3011276344 |
| FEI numbers | 3011276344 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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