Esteya

Basic Information

• Brand Name: Esteya
• Primary DI: 08717213036161
• Version / Model: 187115-03
• Company Name: Nucletron B.V.
• Labeler DUNS: 415269930
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 674ff9c4-5e72-481e-bc69-7a99af73f62c

Device Description

Esteya Surface Applicator Set

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
Primary	08717213036161	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132092	000