Esteya

Basic Information

• Brand Name: Esteya
• Primary DI: 08717213050976
• Version / Model: 187123P01-03
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6d952316-7c7c-49af-8aa6-da890dd7e04f

Device Description

Surface Applicator, Zero

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: No
• Has Lot/Batch Number: Yes
• 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
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
Direct Marking	08717213036178	GS1
Primary	08717213050976	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132092	000