FDA.reportPublic FDA data

XACT Robotics: Harness (L)

Primary DI
07290017702186
Brand
XACT Robotics: Harness (L)
Company
XACT ROBOTICS LTD
Model
A
Catalog number
XR-LG-HRN
Device description
Large Harness
Published
2023-01-19
Public version status
New
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
17290017702183PackageGS15In Commercial Distribution
07290017702186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001770218317290017702183
07290017702186072900177021867290017702186

GMDN Terms#

Term, Definition table
TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

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

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
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
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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B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
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
04987670105579Aquilion ONECANON INC.JAK2025-01-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
17630039302051Remote ControlBracco Injeneering SAJAK2024-05-29
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)Auris Health, Inc.JAK2024-05-05
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
37630039301980IV PoleBracco Injeneering SAJAK2024-03-01