BIOPSYBELL SRL

Address:Via A.Manuzio n.24,MIRANDOLA Modena,IT

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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

Biopsy Needle (FCG) (4) Injector, Vertebroplasty (Does Not Contain Cement) (OAR) (3) Instrument, Biopsy (KNW) (3) Device, Percutaneous, Biopsy (MJG) (1) Mixer, Cement, For Clinical Use (JDZ) (1) Spinal Channeling Instrument, Vertebroplasty (OCJ) (1)

Premarket Exempt

No Yes

Clear

BIOPSYBELL SRL - 08033860000363 Catalog Number : OBE1110T

Device Class : 2

Duns Number: 438746708

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860002008 Catalog Number : ULSEC1115C

Device Description : NEEDLE FOR BONE-MARROW BIOPSY

Device Class : 2

Duns Number: 438746708

Premarket Exempt : No

Product Code : KNW, FCG

Prescription Use : No

Device Count : 1

BIOPSYBELL - 08033860002299 Catalog Number : ULSEC0815C

Device Description : NEEDLE FOR BONE-MARROW BIOPSY

Device Class : 2

Duns Number: 438746708

Premarket Exempt : No

Product Code : KNW, FCG

Prescription Use : No

Device Count : 1

BIOPSYBELL - 08033860003449 Catalog Number : KVTMIXN

Device Description : Vertebroplasty / Kyphoplasty cement mixing system

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860010843 Catalog Number : KVTGUN-DS

Device Description : Device for cement infusion in the vertebroplasty procedures

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860015374 Catalog Number : RESWD1115C

Device Description : KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : OCJ

Prescription Use : Yes

Device Count : 1

Biopsybell - 08033860016296 Catalog Number : GUN1415EC-OS

Device Description : Automatic guillotine needle for soft tissue biopsy

Device Class : 2

Duns Number: 438746708

Premarket Exempt : No

Product Code : FCG

Prescription Use : No

Device Count : 1

BIOPSYBELL - 08033860016739 Catalog Number : 03.51.10.0173

Device Description : Fenestrated Screw Percutaneous Cannula

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860016760 Catalog Number : 03.51.10.0174

Device Description : Fenestrated Screw Percutaneous Cannula

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : OAR

Prescription Use : Yes

Device Count : 1

BIOPSYBELL SRL - 08033860016883 Catalog Number : STR1410EC

Device Description : Aghi per biopsia / Biopsy needles

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

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