Robotic Tool Kit Knot Pusher Closed

GUDID B040RTKRKP1

Suture Knot Pusher with Closed Tip

GENESEE BIOMEDICAL, INC.

Suture knot pusher, reusable
Primary Device IDB040RTKRKP1
NIH Device Record Key15d5254e-c218-4b62-ab13-4dc7b65a50b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRobotic Tool Kit Knot Pusher Closed
Version Model NumberRTK-RKP
Company DUNS939872651
Company NameGENESEE BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB040RTKRKP0 [Primary]
HIBCCB040RTKRKP1 [Package]
Contains: B040RTKRKP0
Package: [1 Units]
In Commercial Distribution

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


[B040RTKRKP1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-13
Device Publish Date2024-12-05

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