KUBTEC

Basic Information

• Brand Name: KUBTEC
• Primary DI: B619X800
• Version / Model: XPERT 80
• Company Name: Kubtec
• Labeler DUNS: 361955128
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-22
• Public Version: 7
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: cc46cf99-92d0-4123-8641-1211754e769a

Device Description

Specimen x-ray system

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MWP	Cabinet,X-Ray System	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42280	Tissue specimen x-ray system IVD	An assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B619X800	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071233	000