Self-Righting Needle Holder

Primary DI
17290017376193
Brand
Self-Righting Needle Holder
Company
HUMAN XTENSIONS LTD
Model
20-30-077-01
Catalog number
20-30-077-01
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223718000HandX™ Self-Righting Needle HolderHuman Xtensions , Ltd.2023-06-05GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017376193PackageGS16In Commercial Distribution
07290017376196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001737619317290017376193
07290017376196072900173761967290017376196

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.

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
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 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
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
17290017376001HandX20-30-019-0120-30-019-012018-09-06
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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