- Physicians Office Resource

MONOPTY® Disposable Core Biopsy Instrument, 22mm penetration depth, 14g x 10cm
MONOPTY - 121410

Device Description

A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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 single-use device.

Environmental Conditions

No Data Available

Device Sizes

Needle Gauge: 14 Gauge

Length: 10 Centimeter

Penetration Depth, 22 Millimeters

Needle Gauge: 14 Gauge
Length: 10 Centimeter
Penetration Depth, 22 Millimeters

Device Sterilization

Device Sterile: True

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 Identifiers

Device Id: 10801741084581

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741084584

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741084584

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

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