Dexter L6 Handle Grip 146

GUDID 07640184840158

Dexter L6 Handle Grip

Distalmotion SA

Robotic surgical arm system

• Primary Device ID: 07640184840158
• NIH Device Record Key: 9571b422-bd48-4153-a5ce-0a8b945cf523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dexter L6 Handle Grip
• Version Model Number: Dexter L6
• Catalog Number: 146
• Company DUNS: 486345080
• Company Name: Distalmotion SA
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com
• Phone: 216-744-2602
• Email: support@distalmotion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640184840158 [Primary]
GS1	07640184840165 [Package]; Package: Carboard box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN230084

FDA Product Code

• SDD: Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

[07640184840158]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-02
• Device Publish Date: 2024-11-24

Devices Manufactured by Distalmotion SA

• 07640184840141 - Dexter L6 Accessory tray: 2024-12-02 Dexter L6 Accessory tray
• 07640184840158 - Dexter L6 Handle Grip: 2024-12-02Dexter L6 Handle Grip
• 07640184840158 - Dexter L6 Handle Grip: 2024-12-02 Dexter L6 Handle Grip
• 07640184840189 - Dexter L6 Incision Pointer: 2024-12-02 Dexter L6 Incision Pointer
• 07640184840400 - Dexter L6 Emergency Release Tool: 2024-12-02 Dexter L6 Emergency Release Tool
• 07640184840226 - Dexter L6 Endoscope Cart: 2024-12-02 Dexter L6 Endoscope Cart
• 07640184840240 - Dexter Sterile Interface: 2024-12-02 Dexter L6 Sterile Interface
• 07640184840424 - Dexter Bipolar Maryland Dissector: 2024-12-02 Dexter L6 Bipolar Maryland Dissector
• 07640184840448 - Dexter Bipolar Johann Grasper: 2024-12-02 Dexter L6 Bipolar Johann Grasper