Dexter Needle Holder

Basic Information

• Brand Name: Dexter Needle Holder
• Primary DI: 07640184840646
• Version / Model: Dexter L6
• Catalog Number: 516
• 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: 7185c57a-6592-447f-9821-3b919c2958ea

Device Description

Dexter L6 Needle Holder

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
Package	07640184840653	GS1	Cardboard box	4	In Commercial Distribution
Primary	07640184840646	GS1

Customer Contacts

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