BIOPSYBELL ULSEC0815C

GUDID 08033860002305

NEEDLE FOR BONE-MARROW BIOPSY

BIOPSYBELL SRL

Liver biopsy procedure kit

• Primary Device ID: 08033860002305
• NIH Device Record Key: 49dacf86-9b0a-43fd-b0d5-c02ce0001384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPSYBELL
• Version Model Number: UNLUX SYSTEM
• Catalog Number: ULSEC0815C
• Company DUNS: 438746708
• Company Name: BIOPSYBELL SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: medical@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it
• Phone: +39053527850
• Email: support@biopsybell.it

Device Dimensions

• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter
• Needle Gauge: 8 Gauge
• Length: 150 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033860002299 [Primary]
GS1	08033860002305 [Package]; Contains: 08033860002299; Package: BLISTER [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130616

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-11
• Device Publish Date: 2021-03-03

On-Brand Devices [BIOPSYBELL]

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