- Physicians Office Resource

Trek™ Bone Lesion Biopsy Kit, 11g x 15cm Introducer, 13g x 19.8cm Biopsy
Trek - TKL1115

Device Description

A collection of sterile devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Length: 19.8 Centimeter

Needle Gauge: 13 Gauge

Length: 19.8 Centimeter
Needle Gauge: 13 Gauge

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: 10801741201469

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741201462

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741201462

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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