M-Biopsy Needle For Reusable Biopsy Instruments N20416016

GUDID 25711055001698

The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy® Biopsy Needle for a Bard® Magnum® or Pro-Mag™ Biopsy Instrument.

Mermaid Medical A/S

Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID25711055001698
NIH Device Record Keye5ee5e7d-afd9-440d-a534-c45c1c2287e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameM-Biopsy Needle For Reusable Biopsy Instruments
Version Model NumberN20416016
Catalog NumberN20416016
Company DUNS308951313
Company NameMermaid Medical A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com
Phone+4547108570
Emailcustomer@mermaidmedical.com

Device Dimensions

Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter
Needle Gauge16 Gauge
Length10 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight and keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS115711055001691 [Primary]
GS125711055001698 [Package]
Contains: 15711055001691
Package: retail box [10 Units]
In Commercial Distribution

FDA Product Code

DWONeedle, Biopsy, Cardiovascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-11
Device Publish Date2023-10-03

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.