SOMATEX 900400-US

GUDID 08033860021689

BIOPSYBELL SRL

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 08033860021689
• NIH Device Record Key: 507cd9b7-ae10-4940-a3e4-1ea6114a24b0
• Commercial Distribution Discontinuation: 2025-04-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SOMATEX
• Version Model Number: SOMACORE VERIFY
• Catalog Number: 900400-US
• 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: true
• 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: 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

Device Dimensions

• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge
• Length: 100 Millimeter
• Needle Gauge: 18 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033860021672 [Primary]
GS1	08033860021689 [Package]; Contains: 08033860021672; Package: [5 Units]; Discontinued: 2025-04-28; Not 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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-04-29
• Device Publish Date: 2016-08-01

On-Brand Devices [SOMATEX]

• 08033860021863: SOMACORE VERIFY S
• 08033860021849: SOMACORE VERIFY S
• 08033860021825: SOMACORE VERIFY S
• 08033860021801: SOMACORE VERIFY S
• 08033860021788: SOMACORE VERIFY S
• 08033860021764: SOMACORE VERIFY
• 08033860021740: SOMACORE VERIFY
• 08033860021726: SOMACORE VERIFY
• 08033860021702: SOMACORE VERIFY
• 08033860021689: SOMACORE VERIFY
• 08033860021665: SOMACORE VERIFY
• 08033860021641: SOMACORE VERIFY
• 08033860021627: SOMACORE VERIFY
• 08033860021603: SOMACORE VERIFY