Dexter L6 Robot 710

GUDID 07640184840516

Dexter L6 - Patient Cart 1 Dexter L6 - Patient Cart 2 Dexter L6 - Surgeon Console

Distalmotion SA

Robotic surgical arm system
Primary Device ID07640184840516
NIH Device Record Key4841ba61-d7e3-4ef0-85c8-e3da6e22d5b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexter L6 Robot
Version Model NumberDexter L6
Catalog Number710
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
GS107640184840516 [Primary]

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 Sterilefalse

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 Grasper2024-12-02 Dexter L6 Bipolar Johann Grasper

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