Home GUDID B040RTKRKP1 Robotic Tool Kit Knot Pusher Closed
Primary DI B040RTKRKP1
Brand Robotic Tool Kit Knot Pusher Closed
Company GENESEE BIOMEDICAL, INC.
Model RTK-RKP
Device description Suture Knot Pusher with Closed Tip
Published 2024-12-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name DWS Instruments, Surgical, Cardiovascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWS Instruments, Surgical, Cardiovascular Cardiovascular 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B040RTKRKP1 Package HIBCC 1 In Commercial Distribution B040RTKRKP0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Suture knot pusher, reusable A hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 939872651 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B040RPS181100 Thoracic Port with Obturator 18x110mm RPS-18110 2026-03-25 B040RPS18500 Thoracic Port with Obturator 18x50mm RPS-1850 2026-03-25 B040RPS18700 Thoracic Port with Obturator 18x70mm RPS-1870 2026-03-25 B040RPS18900 Thoracic Port with Obturator 18x90mm RPS-1890 2026-03-25 B040TF260 TransForm McCarthy Annuloplasty Ring TF-26 2024-12-23 B040TF280 TransForm McCarthy Annuloplasty Ring TF-28 2024-12-23 B040TF300 TransForm McCarthy Annuloplasty Ring TF-30 2024-12-23 B040TF320 TransForm McCarthy Annuloplasty Ring TF-32 2024-12-23 B040TF340 TransForm McCarthy Annuloplasty Ring TF-34 2024-12-23 B040TF380 TransForm McCarthy Annuloplasty Ring TF-38 2024-12-23 B040TF400 TransForm McCarthy Annuloplasty Ring TF-40 2024-12-23 B040TF240 TransForm McCarthy Annuloplasty Ring TF-24 2024-12-23 B040TF26 TransForm McCarthy Annuloplasty Ring TF-26 2024-12-23 B040TF28 TransForm McCarthy Annuloplasty Ring TF-28 2024-12-23 B040TF30 TransForm McCarthy Annuloplasty Ring TF-30 2024-12-23 B040TF32 TransForm McCarthy Annuloplasty Ring TF-32 2024-12-23 B040TF34 TransForm McCarthy Annuloplasty Ring TF-34 2024-12-23 B040TF360 TransForm McCarthy Annuloplasty Ring TF-36 2024-12-23 B040TF38 TransForm McCarthy Annuloplasty Ring TF-38 2024-12-23 B040TF40 TransForm McCarthy Annuloplasty Ring TF-40 2024-12-23
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