FDA.reportPublic FDA data

HandX

Primary DI
17290017376001
Brand
HandX
Company
HUMAN XTENSIONS LTD
Model
20-30-019-01
Catalog number
20-30-019-01
Device description
The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulatio
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
false
Single use
false

Product Codes#

Code, Name table
CodeName
NAYSystem, Surgical, Computer Controlled Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017376001PackageGS12In Commercial Distribution
07290017376004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001737600117290017376001
07290017376004072900173760047290017376004

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electromechanical surgical systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity25 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600165869
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
07290017376172Monopolar Scissors20-30-076-0120-30-076-012023-06-07
07290017376196Self-Righting Needle Holder20-30-077-0120-30-077-012023-06-07
17290017376179Monopolar Scissors20-30-076-0120-30-076-012023-06-07
17290017376193Self-Righting Needle Holder20-30-077-0120-30-077-012023-06-07
07290017376165Monopolar Spatula20-30-074-012023-01-16
07290017376011HandX Fenestrated Grasper 5mm20-30-013-0120-30-015-012018-09-06
07290017376028HandX Needle Holder 5mm20-30-011-0120-30-014-012018-09-06
07290017376035HandX Disposables 20-30-008-0120-30-009-012018-09-06
07290017376080Monopolar Hook20-30-044-0120-30-073-012021-06-06
07290017376004HandX20-30-019-0120-30-019-012018-09-06
17290017376018HandX Fenestrated Grasper 5mm20-30-013-0120-30-013-012018-09-06
17290017376025HandX Needle Holder 5mm20-30-011-0120-30-011-012018-09-06
17290017376032HandX Disposables 20-30-008-0120-30-008-012018-09-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14260463842064Power Cord C13Aktormed GmbHNAY2026-09-04
00815440022624SenhanceAsensus Surgical, Inc.NAY2026-03-09
00886874123362da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
00815440022266SenhanceAsensus Surgical, Inc.NAY2025-01-14
00815440022273SenhanceAsensus Surgical, Inc.NAY2025-01-14
00886874120736Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00886874120743Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00815440021924SenhanceAsensus Surgical, Inc.NAY2023-09-19
00815440021825SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440021856SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022235SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022242SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022259SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022280SenhanceAsensus Surgical, Inc.NAY2022-07-11
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00815440021931SenhanceAsensus Surgical, Inc.NAY2020-08-05
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00886874120767EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
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