BIOPSYBELL ULSEC0815C

GUDID 08033860002305

NEEDLE FOR BONE-MARROW BIOPSY

BIOPSYBELL SRL

Liver biopsy procedure kit
Primary Device ID08033860002305
NIH Device Record Key49dacf86-9b0a-43fd-b0d5-c02ce0001384
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOPSYBELL
Version Model NumberUNLUX SYSTEM
Catalog NumberULSEC0815C
Company DUNS438746708
Company NameBIOPSYBELL SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter
Needle Gauge8 Gauge
Length150 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108033860002299 [Primary]
GS108033860002305 [Package]
Contains: 08033860002299
Package: BLISTER [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-11
Device Publish Date2021-03-03

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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