HandX Needle Holder 5mm 20-30-011-01

GUDID 17290017376025

HUMAN XTENSIONS LTD

Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system Endoscopic electromechanical surgical system

• Primary Device ID: 17290017376025
• NIH Device Record Key: a1d7d543-edaa-49db-a54c-4b8188aea149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HandX Needle Holder 5mm
• Version Model Number: 20-30-011-01
• Catalog Number: 20-30-011-01
• Company DUNS: 600165869
• Company Name: HUMAN XTENSIONS LTD
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017376028 [Primary]
GS1	17290017376025 [Package]; Contains: 07290017376028; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-08
• Device Publish Date: 2018-09-06

Devices Manufactured by HUMAN XTENSIONS LTD

• 17290017376179 - Monopolar Scissors: 2023-06-15
• 17290017376193 - Self-Righting Needle Holder: 2023-06-15
• 07290017376080 - Monopolar Hook: 2021-06-14
• 17290017376001 - HandX: 2018-10-08 The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for
• 17290017376018 - HandX Fenestrated Grasper 5mm: 2018-10-08
• 17290017376025 - HandX Needle Holder 5mm: 2018-10-08
• 17290017376025 - HandX Needle Holder 5mm: 2018-10-08
• 17290017376032 - HandX Disposables: 2018-10-08 HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable