BIOPSYBELL SRL ULS0910

GUDID 08033860022228

Needle for bone-marrow biopsy

BIOPSYBELL SRL

Bone marrow biopsy procedure kit

• Primary Device ID: 08033860022228
• NIH Device Record Key: 1dd58d95-3236-49d6-a41c-84d789c0e716
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPSYBELL SRL
• Version Model Number: UNLUX SYSTEM
• Catalog Number: ULS0910
• Company DUNS: 438746708
• Company Name: BIOPSYBELL SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• 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: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter
• Needle Gauge: 9 Gauge
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033860022228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130616

FDA Product Code

• FCG: Biopsy Needle

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: 2023-10-31
• Device Publish Date: 2023-10-23

On-Brand Devices [BIOPSYBELL SRL]

• 08033860016890: Aghi per biopsia / Biopsy needles
• 08033860039240: KYPHOPLASTY TOOL KIT
• 08033860038694: KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP
• 08033860038267: KYPHOPLASTY TOOL KIT
• 08033860037321: KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP
• 08033860032555: NEEDLE FOR BONE MARROW EXPLANT
• 08033860037512: KYPHOPLASTY TOOL KIT
• 08033860037505: KYPHOPLASTY TOOL KIT
• 08033860037499: KYPHOPLASTY TOOL KIT
• 08033860037482: KYPHOPLASTY TOOL KIT
• 08033860041663: NEEDLE FOR BONE MARROW BIOPSY
• 08033860038748: TRACHEOSTOMY HUMIDIFIER (HME)
• 08033860024970: NEEDLE FOR BONE MARROW EXPLANT
• 08033860016111: TRACHEOSTOMY HUMIDIFIER (HME)
• 08033860005832: NEEDLE FOR BONE MARROW EXPLANT
• 08033860002435: Needle for bone-marrow biopsy
• 08033860002411: NEEDLE FOR BONE MARROW EXPLANT
• 08033860002237: NEEDLE FOR BONE MARROW EXPLANT
• 08033860002084: Needle for bone-marrow biopsy
• 08033860001360: Needle for bone-marrow biopsy
• 08033860001001: NEEDLE FOR BONE MARROW EXPLANT
• 08033860000028: NEEDLE FOR BONE MARROW BIOPSY
• 08033860034900: KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP
• 08033860022846: Needle for bone-marrow biopsy
• 08033860009694: Needle for bone-marrow biopsy
• 08033860007331: Needle for bone-marrow biopsy
• 08033860003913: Needle for bone-marrow biopsy
• 08033860003876: Needle for bone-marrow biopsy
• 08033860003852: Needle for bone-marrow biopsy
• 08033860002275: Needle for bone-marrow biopsy
• 08033860002107: NEEDLE FOR BONE MARROW EXPLANT
• 08033860002046: Needle for bone-marrow biopsy
• 08033860000608: NEEDLE FOR BONE MARROW BIOPSY
• 08033860000400: NEEDLE FOR BONE MARROW BIOPSY
• 08033860000042: NEEDLE FOR BONE MARROW BIOPSY
• 08033860042158: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042141: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042134: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042127: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042110: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042103: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042097: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042080: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042073: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042066: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042059: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042042: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042035: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042028: NEEDLE FOR BONE MARROW EXPLANT
• 08033860042011: NEEDLE FOR BONE MARROW EXPLANT