Praxis Medical

Primary DI
00860003935804
Brand
Praxis Medical
Company
PRAXIS MEDICAL LLC
Model
C0025
Device description
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.
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200278000CytoCorePraxis Medical, LLC2020-03-31KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003935811PackageGS15In Commercial Distribution
00860003935828PackageGS118In Commercial Distribution
00860003935804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003935811008600039358118600039358110860003935811
00860003935828008600039358288600039358280860003935828
00860003935804008600039358048600039358040860003935804

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy syringe holder, reusableA hand-operated device designed to hold a biopsy syringe to facilitate precision aspiration of a tissue specimen through a biopsy needle. The holder is typically made of metal and plastic materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
939493362
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850081350002Ion Pouch FRENDO-FR-22G-I2025-11-06
00850081350019Monarch Pouch BVENDO-BV-22G-M2025-11-06
00850081350026Monarch Pouch FRENDO-FR-22G-M2025-11-06
00850081350033Olympus Pouch BVENDO-BV-22G-O2025-11-06
00850081350040Olympus Pouch FRENDO-FR-22G-O2025-11-06
00860003935842EndoCoreEndoCore2025-11-06
00860003935859Ion Pouch BVENDO-BV-22G-I2025-11-06
00860003935866Praxis Medical CytoCore and CytoCore Luer AdaptersC0025L2022-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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