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

Guide, Needle, Surgical (GDF) (8) Biopsy Needle (FCG) (1) Injector, Vertebroplasty (Does Not Contain Cement) (OAR) (1) Instrument, Biopsy (KNW) (1)

Premarket Exempt

No Yes

Clear

BIOPSYBELL - 08033860019501 Catalog Number : 03.51.10.0177

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 - 08033860020033 Catalog Number : 03.52.10.0467

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860020040 Catalog Number : 03.52.10.0468

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

Spine Instruments - 08033860020057 Catalog Number : 03.52.10.0469

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

Spine Instruments - 08033860020064 Catalog Number : 03.52.10.0470

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860020071 Catalog Number : 03.52.10.0463

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860020088 Catalog Number : 03.52.10.0464

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

Spine Instruments - 08033860020095 Catalog Number : 03.52.10.0465

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

Spine Instruments - 08033860020101 Catalog Number : 03.52.10.0466

Device Description : Kyphoplasty kirschner guide

Device Class : 1

Duns Number: 438746708

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

BIOPSYBELL - 08033860021078 Catalog Number : ULS1110R

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

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