Home GUDID 17290017376032 HandX Disposables
Primary DI 17290017376032
Brand HandX Disposables
Company HUMAN XTENSIONS LTD
Model 20-30-008-01
Catalog number 20-30-008-01
Device description HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable
Published 2018-09-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GCJ Laparoscope, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290017376032 Package GS1 6 In Commercial Distribution 07290017376035 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17290017376032 17290017376032 07290017376035 07290017376035 7290017376035
GMDN Terms# Term, Definition table Term Definition Endoscopic electromechanical surgical system An assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility.
Regulatory Flags# DUNS number 600165869 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290017376172 Monopolar Scissors 20-30-076-01 20-30-076-01 2023-06-07 07290017376196 Self-Righting Needle Holder 20-30-077-01 20-30-077-01 2023-06-07 17290017376179 Monopolar Scissors 20-30-076-01 20-30-076-01 2023-06-07 17290017376193 Self-Righting Needle Holder 20-30-077-01 20-30-077-01 2023-06-07 07290017376165 Monopolar Spatula 20-30-074-01 2023-01-16 07290017376011 HandX Fenestrated Grasper 5mm 20-30-013-01 20-30-015-01 2018-09-06 07290017376028 HandX Needle Holder 5mm 20-30-011-01 20-30-014-01 2018-09-06 07290017376035 HandX Disposables 20-30-008-01 20-30-009-01 2018-09-06 07290017376080 Monopolar Hook 20-30-044-01 20-30-073-01 2021-06-06 07290017376004 HandX 20-30-019-01 20-30-019-01 2018-09-06 17290017376001 HandX 20-30-019-01 20-30-019-01 2018-09-06 17290017376018 HandX Fenestrated Grasper 5mm 20-30-013-01 20-30-013-01 2018-09-06 17290017376025 HandX Needle Holder 5mm 20-30-011-01 20-30-011-01 2018-09-06
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