FDA.reportPublic FDA data

XACT Robotics: 17g Needle Threading Jig

Primary DI
07290017702049
Brand
XACT Robotics: 17g Needle Threading Jig
Company
XACT ROBOTICS LTD
Model
A
Catalog number
XR-17G-IIK
Device description
17G Instrument Insertion Kit
Published
2023-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191332000XACT Robotic SystemXact Robotics, Ltd.2019-10-03JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017702046PackageGS15In Commercial Distribution
07290017702049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001770204617290017702046
07290017702049072900177020497290017702049

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical needle holder, single-useA surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+18883179228customerservice@xactrobotics.com

Regulatory Flags#

DUNS number
600405981
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017702018XACT ACE RobotBXR-ACE-RBT2023-01-19
07290017702254ACEDXR-ACE-SYS2022-07-20
07290017702094XACT Robotics: Robot DrapeAXR-RBT-DRP2023-01-19
07290017702155XACT Robotics: Disposable KitAXR-DIS-KIT2023-01-19
07290017702100Respiration Sensor DrapeAXR-RS-DRP2023-01-19
07290017702247Aiming Plate DrapeBXR-AP-DRP2023-01-19
17290017702091XACT Robotics: Robot DrapeAXR-RBT-DRP2023-01-19
17290017702152XACT Robotics: Disposable KitAXR-DIS-KIT2023-01-19
072900177023081.5mm Ablation Instrument Insertion KitAXR-1.5MM-ABL-IIK2023-08-03
07290017702056XACT Robotics: 18g Needle Threading JigAXR-18G-IIK2023-01-19
07290017702063XACT Robotics: 19g Needle Threading JigAXR-19G-IIK2023-01-19
07290017702179Attachment PillowsBXR-ATT-PLW2023-01-19
07290017702186XACT Robotics: Harness (L) AXR-LG-HRN2023-01-19
07290017702193XACT Robotics: Harness (XL) AXR-XL-HRN2023-01-19
07290017702209XACT Robotics: Harness (M) AXR-MD-HRN2023-01-19
07290017702216XACT Robotics: Harness (S) AXR-SM-HRN2023-01-19
07290017702223XACT Robotics: Respiration Sensor All Around StrapAXR-RS-AAS2023-01-19
07290017702230Attachment TowelBXR-ATT-TWL2023-01-19
07290017702261XACT Robotics: Respiration Sensor Harness StrapAXR-RS-HRN2023-01-19
07290017702278Frame-Harness Strap SetAXR-FRM-HRN2023-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.JAK2026-10-19
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICALJAK2026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICALJAK2026-10-19
19356870000045CAC4DMEDICAL LIMITEDJAK2026-10-13
19356870000090LDA4DMEDICAL LIMITEDJAK2026-10-13
00860016243804C-beamPulmera, Inc.JAK2026-10-10
00884838120433SmartCTPhilips Medical Systems Nederland B.V.JAK2026-09-28
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
00884838129559CT Areta RT/Rembra RT UpgradesPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-08-21
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
00884838129528CT RembraPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129535CT Rembra RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129542CT Areta RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24