Dexter L6 Robot

Basic Information

• Brand Name: Dexter L6 Robot
• Primary DI: 07640184840684
• Version / Model: Dexter L6
• Catalog Number: 105
• Company Name: Distalmotion SA
• Labeler DUNS: 486345080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-07
• Public Version: 2
• Public Version Date: 2026-03-19
• Public Version Status: Update
• Public Device Record Key: 9e52319a-ce79-4f2c-ac80-75fd1968a4ec

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SDD	Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field	General, Plastic Surgery	878.4965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38678	Robotic surgical telemanipulation system	An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640184840684	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]