Biopsybell SB1847EC

GUDID 08033860043209

Semiautomatic guillotine needle for soft-tissue biopsy

BIOPSYBELL SRL

End-cut biopsy gun handpiece/needle
Primary Device ID08033860043209
NIH Device Record Key7d2d9183-c1fd-4332-a229-cc71252c57de
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiopsybell
Version Model NumberSPEEDYBELL
Catalog NumberSB1847EC
Company DUNS438746708
Company NameBIOPSYBELL SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it
Phone+39053527850
Emailsupport@biopsybell.it

Device Dimensions

Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge
Length470 Millimeter
Needle Gauge18 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS108033860043209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCGBiopsy Needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-13
Device Publish Date2023-09-05

On-Brand Devices [Biopsybell]

08033860036317ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860002305NEEDLE FOR BONE-MARROW BIOPSY
08033860002008NEEDLE FOR BONE-MARROW BIOPSY
08033860039509KYPHOPLASTY BONE FILLER KIT
08033860036690ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036683ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036676ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036669ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036652ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036645ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036638ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036621ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860036324ASPIRATION/EXPLANT OF BONE MARROW THROUGH A PISTON SYRINGE
08033860037901Kyphoplasty kirschner guide
08033860030445Fenestrated Screw Percutaneous Cannula
08033860030254Fenestrated Screw Percutaneous Cannula
08033860025465Kyphoplasty kirschner guide
08033860025458Kyphoplasty kirschner guide
08033860025441Kyphoplasty kirschner guide
08033860025434Kyphoplasty kirschner guide
08033860020088Kyphoplasty kirschner guide
08033860020071Kyphoplasty kirschner guide
08033860020040Kyphoplasty kirschner guide
08033860020033Kyphoplasty kirschner guide
08033860019501Fenestrated Screw Percutaneous Cannula
08033860016760Fenestrated Screw Percutaneous Cannula
08033860016739Fenestrated Screw Percutaneous Cannula
08033860024567KYPHOPLASTY BONE FILLER KIT
08033860015381KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP
08033860038724KYPHOPLASTY DRILL
08033860036591Device for cement infusion in the vertebroplasty procedures
08033860025076BONE ACCESS NEEDLE
08033860030223Device for cement infusion in the vertebroplasty procedures
08033860036430BONE ACCESS NEEDLE
08033860030278SUBCHONDRAL BONE PLASTY
08033860019747DISC DECOMPRESSION NEEDLE
08033860019693DISC DECOMPRESSION NEEDLE
08033860021078NEEDLE FOR BONE-MARROW BIOPSY
08033860037826KYPHOPLASTY BALLOON CATHETER
08033860030193KYPHOPLASTY BALLOON CATHETER
08033860030186KYPHOPLASTY BALLOON CATHETER
08033860024857BONE ACCESS NEEDLE
08033860017927BONE ACCESS NEEDLE
08033860002480NEEDLE FOR BONE-MARROW BIOPSY
08033860001810NEEDLE FOR BONE-MARROW BIOPSY
08033860001056NEEDLE FOR BONE-MARROW BIOPSY
08033860016302Automatic guillotine needle for soft tissue biopsy
08033860016258Needle for bone-marrow explant
08033860011277Semiautomatic guillotine needle for soft-tissue biopsy
08033860004019Semiautomatic guillotine needle for soft-tissue biopsy

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