MAGNUM® Reusable Core Biopsy Instrument
MAGNUM - MG1522
Device Description
A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KNW
Device Name: Instrument, Biopsy
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.1075
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 00801741083945
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A