FDA.reportPublic FDA data

XACT Robotics: Robot Drape

Primary DI
17290017702091
Brand
XACT Robotics: Robot Drape
Company
XACT ROBOTICS LTD
Model
A
Catalog number
XR-RBT-DRP
Device description
Robot Medical Drape
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
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
17290017702091PackageGS115In Commercial Distribution
07290017702094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001770209117290017702091
07290017702094072900177020947290017702094

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
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
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