FDA.reportPublic FDA data

XACT Robotics: Disposable Kit

Primary DI
17290017702152
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
OTC
false
Sterile
false
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 drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
600405981
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 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
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
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10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
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M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12