Sun Capsule Tanning Booth

Basic Information

• Brand Name: Sun Capsule Tanning Booth
• Primary DI: B397ULTRATEN0
• Version / Model: Ultra Ten
• Catalog Number: Ultra Ten
• Company Name: SUN CAPSULE, INC.
• Labeler DUNS: 801365706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b54d2862-1588-4617-a1f6-40ade0b16fb2
• Distribution End Date: 2027-12-31

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
LEJ	Booth, Sun Tan	General, Plastic Surgery	878.4635	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46387	Ultraviolet tanning device	A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B397ULTRATEN0	HIBCC

Customer Contacts

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