XACT ACE Xtend

Basic Information

• Brand Name: XACT ACE Xtend
• Primary DI: 07290017702384
• Version / Model: B
• Catalog Number: XR-ACE-XTEND
• Company Name: XACT ROBOTICS LTD
• Labeler DUNS: 600405981
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-19
• Public Version: 1
• Public Version Date: 2023-01-27
• Public Version Status: New
• Public Device Record Key: 65d0a382-cda2-4d31-93f7-74915f6ef3fe

Device Description

XACT ACE Xtend

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62940	Computer/medical device keyboard	A desktop, electronic component of a computer/medical device intended to operate and/or control the use of the parent device. It has a panel of keys, including alpha-numeric characters, and may have touchscreen capability and/or specialized keys to control specialized functionality of the parent device. It is not dedicated to those with a disability.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017702384	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221116	000