M-Biopsy Needle For Reusable Biopsy Instruments N20116013

GUDID 25711055001308

The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with a BARD® Magnum™ Biopsy Instrument.

Mermaid Medical A/S

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 25711055001308
• NIH Device Record Key: 47561174-b8e1-4977-bbb5-feebc308c05a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Biopsy Needle For Reusable Biopsy Instruments
• Version Model Number: N20116013
• Catalog Number: N20116013
• Company DUNS: 308951313
• Company Name: Mermaid Medical A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter
• Needle Gauge: 16 Gauge
• Length: 13 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	15711055001301 [Primary]
GS1	25711055001308 [Package]; Contains: 15711055001301; Package: Retail Box [10 Units]; In Commercial Distribution

FDA Product Code

• DWO: Needle, Biopsy, Cardiovascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-04
• Device Publish Date: 2019-08-05

On-Brand Devices [M-Biopsy Needle For Reusable Biopsy Instruments]

• 25711055001780: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001773: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001742: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001735: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001728: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001711: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001704: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001681: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001674: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001667: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001636: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001629: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001612: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001605: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001599: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001582: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001575: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001568: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001551: The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such
• 25711055001544: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001537: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001513: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001506: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001490: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001483: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001476: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001469: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001452: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001445: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001438: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001421: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001414: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001407: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001391: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001384: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001377: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001360: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001353: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001346: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001339: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001322: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001315: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001308: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001292: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001285: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001278: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001261: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001254: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001247: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the
• 25711055001230: The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the