apriomed.comAPrioCore Plus
AprioMed AB
AprioMed AB
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007664053 | 3007664053 | AprioMed AB | 1 | N | 2027-01-01 | Virdings alle 28 UPPSALA SE 754 50 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07350031350623 | Bonopty Penetration Set - Manually operated, sterile, single use coaxial bone biopsy system | +46184301440 | info@apriomed.com |
| 07350031350630 | Bonopty Biopsy Set - Manually operated, sterile, single use coaxial bone biopsy system | +46184301440 | info@apriomed.com |
| 07350031350722 | Bonopty Penetration Set - Manually operated, sterile, single use coaxial bone biopsy system | +46184301440 | info@apriomed.com |
| 07350031350739 | Bonopty Biopsy Set - Manually operated, sterile, single use coaxial bone biopsy system | +46184301440 | info@apriomed.com |
| 07350031350746 | Bonopty Extended Drill - Extended drill that can be used together with AprioMed Bonopty Penetration Set 14G. | +46184301440 | info@apriomed.com |
| 07350031350821 | Bonopty Penetration Set - Manually operated, sterile, single use coaxial bone biopsy system | +46184301440 | info@apriomed.com |
| 07350031350838 | Bonopty Biopsy Set - Manually operated, sterile, single use coaxial bone biopsy system | +46184301440 | info@apriomed.com |
| 07350031351194 | Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 12G x 12.1 cm. | +46184301440 | info@apriomed.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 64952 | 1001447984 | K193268 | APrioCore Plus | KNW | 2020-02-27 |
| 64952 | 1611206096 | K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | FCG | 2018-12-18 |
| 64952 | 1971395492 | K150625 | Morrison Steerable Needle | KNW | 2015-06-09 |
| 64952 | 1030275170 | ||||
| 64952 | 1414605953 | ||||
| 64952 | 1731606677 |
Product Codes Associated With Registrations#
PMN#
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
AprioMed AB
Morrison Steerable Needle
APRIOMED AB
GUDID#
Bonopty Penetration Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-02
Bonopty Biopsy Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-01
Bonopty Penetration Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-04
Bonopty Biopsy Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-04
Bonopty Extended Drill - Extended drill that can be used together with AprioMed Bonopty Penetration Set 14G.
2020-12-04
Bonopty Penetration Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-04
Bonopty Biopsy Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-04
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 12G x 12.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 7.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 12.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 17.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 15G x 7.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 15G x 12.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 15G x 17.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 7.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 12.1 cm.
2019-01-21
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 17.1 cm.
2019-01-21
Gangi-HydroGuard Coaxial Needle - Gangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 15G x 12.1cm.
2019-01-21
Gangi-HydroGuard Coaxial Needle - Gangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 15G x 17.1cm.
2019-01-21
Gangi-HydroGuard Coaxial Needle - Gangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 17G x 12.1cm.
2019-01-21
Gangi-HydroGuard Coaxial Needle - Gangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 17G x 17.1cm.
2019-01-21
Bonopty Adapter - Universal connector compatible with AprioMed Bonopty drills.
2020-12-04
Bonopty Penetration Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-04
Bonopty Biopsy Set - Manually operated, sterile, single use coaxial bone biopsy system
2020-12-04
Bonopty Extended Drill - Extended drill that can be used together with AprioMed Bonopty Penetration Set 12G.
2020-12-04
SeeStar - A passive guide for guided invasive access
2020-12-04
SeeStar - A passive guide for guided invasive access
2020-12-04
SeeStar - A passive guide for guided invasive access
2020-12-04
SeeStar - A passive guide for guided invasive access
2020-12-04
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 12G x 12.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 7.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 12.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 13G x 17.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 15G x 7.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 15G x 12.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 15G x 17.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 7.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 12.1 cm.
2023-04-24
Gangi-SoftGuard Coaxial Needle - Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded solid blunt-tip stylet, 17G x 17.1 cm.
2023-04-24
Gangi-HydroGuard Coaxial Needle - Gangi-HydroGuard Coaxial Needle is a sterile, single use coaxial guiding needle with a spring loaded hollow blunt-tip stylet, 15G x 12.1cm.
2023-04-24