DEVICE: XACT Robotics: Disposable Kit (07290017702155)

Device Identifier (DI) Information

XACT Robotics: Disposable Kit
A
In Commercial Distribution
XR-DIS-KIT
XACT ROBOTICS LTD
07290017702155
GS1

1
600405981 *Terms of Use
XACT Robotics: Disposable Kit
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
12535 Medical equipment/instrument drape, single-use
A 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.
Active false
66382 Robotic surgical needle holder, single-use
A 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.
Active false
61131 Radiological general body-part positioner
A 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.
Active false
64491 Medical/surgical interventional tube/cable securement strap
A strip of material in the form of tape/strap intended to be used to secure interventional patient tubes/cables to drapes or device covers in surgical/medical settings; it is not intended to attach to the patient and has no additional intended uses. It may be comprised of, e.g., an adhesive on one side to allow attachment to a drape/cover and Velcro on the other side for securing tubing/cables. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JAK System, X-Ray, Tomography, Computed
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K191332 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

fe17c099-79b7-4827-9305-a26fc617bbe3
September 11, 2024
3
January 19, 2023
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
17290017702152 10 07290017702155 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+18883179228
customerservice@xactrobotics.com
CLOSE