FDA.reportPublic FDA data

XACT Robotics: Disposable Kit

Primary DI
07290017702155
Brand
XACT Robotics: Disposable Kit
Company
XACT ROBOTICS LTD
Model
A
Catalog number
XR-DIS-KIT
Device description
XACT Robotics: Disposable Kit
Published
2023-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
17290017702152PackageGS110In Commercial Distribution
07290017702155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001770215217290017702152
07290017702155072900177021557290017702155

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
600405981
Device count
1
Kit
true
Lot or batch
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
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
07290017702049XACT Robotics: 17g Needle Threading JigAXR-17G-IIK2023-01-19
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
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
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
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29