HandX 20-30-019-01

GUDID 17290017376001

The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulatio

HUMAN XTENSIONS LTD

Endoscopic electromechanical surgical system

• Primary Device ID: 17290017376001
• NIH Device Record Key: 441008c1-01fc-44ce-9ad7-80526434b0e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HandX
• Version Model Number: 20-30-019-01
• Catalog Number: 20-30-019-01
• 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: false
• Lot Batch: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017376004 [Primary]
GS1	17290017376001 [Package]; Contains: 07290017376004; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• NAY: System, Surgical, Computer Controlled Instrument

Sterilization

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

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: 2018-10-08The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulatio
• 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
• 17290017376032 - HandX Disposables: 2018-10-08 HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable