Dexter Bipolar Johann Grasper 703

GUDID 07640184840448

Dexter L6 Bipolar Johann Grasper

Distalmotion SA

Robotic surgical arm system
Primary Device ID07640184840448
NIH Device Record Key9553d477-a664-4ade-9f90-6a4a2dd00469
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexter Bipolar Johann Grasper
Version Model NumberDexter L6
Catalog Number703
Company DUNS486345080
Company NameDistalmotion SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com
Phone216-744-2602
Emailsupport@distalmotion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640184840431 [Primary]
GS107640184840448 [Package]
Contains: 07640184840431
Package: Carboard box [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-02
Device Publish Date2024-11-24

Devices Manufactured by Distalmotion SA

07640184840141 - Dexter L6 Accessory tray2024-12-02 Dexter L6 Accessory tray
07640184840158 - Dexter L6 Handle Grip2024-12-02 Dexter L6 Handle Grip
07640184840189 - Dexter L6 Incision Pointer2024-12-02 Dexter L6 Incision Pointer
07640184840400 - Dexter L6 Emergency Release Tool2024-12-02 Dexter L6 Emergency Release Tool
07640184840226 - Dexter L6 Endoscope Cart2024-12-02 Dexter L6 Endoscope Cart
07640184840240 - Dexter Sterile Interface2024-12-02 Dexter L6 Sterile Interface
07640184840424 - Dexter Bipolar Maryland Dissector2024-12-02 Dexter L6 Bipolar Maryland Dissector
07640184840448 - Dexter Bipolar Johann Grasper2024-12-02Dexter L6 Bipolar Johann Grasper
07640184840448 - Dexter Bipolar Johann Grasper2024-12-02 Dexter L6 Bipolar Johann Grasper

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