BIOPSYBELL SRL ULS1310

GUDID 08033860043414

Needle for bone-marrow biopsy

BIOPSYBELL SRL

Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit Bone marrow biopsy procedure kit

• Primary Device ID: 08033860043414
• NIH Device Record Key: 0d25850a-f7d2-4c29-ae91-9daae7218a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPSYBELL SRL
• Version Model Number: UNLUX SYSTEM
• Catalog Number: ULS1310
• 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: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter
• Needle Gauge: 13 Gauge
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033860043414 [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