Apriomed AB

Address:Virdings alle 28,UPPSALA,SE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Needle, Aspiration And Injection, Disposable (GAA) (7) Instrument, Biopsy (KNW) (2) Biopsy Needle (FCG) (1)

Premarket Exempt

No Yes

Clear

AprioCore plus - 07350031350159 Catalog Number : ACP16-145-20

Device Description : AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.

Device Class :

Duns Number: 631734758

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

AprioCore plus - 07350031350166 Catalog Number : ACP16-195-20

Device Description : AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.

Device Class :

Duns Number: 631734758

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Bonopty Penetration Set - 07350031350623 Catalog Number : 10-1062

Device Description : Manually operated, sterile, single use coaxial bone biopsy system

Device Class :

Duns Number: 631734758

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bonopty Biopsy Set - 07350031350630 Catalog Number : 10-1063

Device Description : Manually operated, sterile, single use coaxial bone biopsy system

Device Class :

Duns Number: 631734758

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bonopty Penetration Set - 07350031350722 Catalog Number : 10-1072

Device Description : Manually operated, sterile, single use coaxial bone biopsy system

Device Class :

Duns Number: 631734758

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bonopty Biopsy Set - 07350031350739 Catalog Number : 10-1073

Device Description : Manually operated, sterile, single use coaxial bone biopsy system

Device Class :

Duns Number: 631734758

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bonopty Extended Drill - 07350031350746 Catalog Number : 10-1074

Device Description : Extended drill that can be used together with AprioMed Bonopty Penetration Set 14G.

Device Class :

Duns Number: 631734758

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bonopty Penetration Set - 07350031350821 Catalog Number : 10-1082

Device Description : Manually operated, sterile, single use coaxial bone biopsy system

Device Class :

Duns Number: 631734758

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bonopty Biopsy Set - 07350031350838 Catalog Number : 10-1083

Device Description : Manually operated, sterile, single use coaxial bone biopsy system

Device Class :

Duns Number: 631734758

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Gangi-SoftGuard Coaxial Needle - 07350031351194 Catalog Number : SG12-121

Device Description : Gangi-SoftGuard Coaxial Needle is a sterile, single use coaxial guiding needle w 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.

Device Class : 2

Duns Number: 631734758

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

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