Sensus

Basic Information

• Brand Name: Sensus
• Primary DI: 10850002237020
• Version / Model: SRT-100 Vision
• Company Name: SENSUS HEALTHCARE, INC.
• Labeler DUNS: 025068307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-12
• Public Version: 1
• Public Version Date: 2019-01-14
• Public Version Status: New
• Public Device Record Key: 7a01086e-e8d4-4794-b39e-386b35f91cfc

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAD	System, Therapeutic, X-Ray	Radiology	892.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41023	Skin-tumour low-voltage therapeutic x-ray system	An assembly of devices designed to deliver low-voltage x-ray beams used in palliative or curative treatments of superficial skin tumours. Acceleration voltages associated with this kind of x-ray therapy system are usually below 100 kV.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850002237020	GS1

Premarket Submissions

Submission Number	Supplement Number
K150037	000