Praxis Medical

GUDID 00860003935804

The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor which rotates the needle clockwise and counterclockwise motion to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.

PRAXIS MEDICAL LLC

Biopsy syringe holder, reusable

• Primary Device ID: 00860003935804
• NIH Device Record Key: 63760b3f-0343-485f-a9fd-1445af7df8dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Praxis Medical
• Version Model Number: C0025
• Company DUNS: 939493362
• Company Name: PRAXIS MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00860003935804 [Primary]
GS1	00860003935811 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	00860003935828 [Package]; Contains: 00860003935811; Package: [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200278

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-17
• Device Publish Date: 2020-08-07

Devices Manufactured by PRAXIS MEDICAL LLC

• 00860003935866 - Praxis Medical CytoCore and CytoCore Luer Adapters: 2022-06-15 CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835)
• 00860003935804 - Praxis Medical: 2020-08-17The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor which rotates the needle clockwise and counterclockwise motion to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.
• 00860003935804 - Praxis Medical: 2020-08-17 The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is eq