JK

Basic Information

• Brand Name: JK
• Primary DI: 04054657500358
• Version / Model: Strahler JK 60/80 EF- Einzelv.
• Catalog Number: 8003 2000
• Company Name: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
• Labeler DUNS: 312827900
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-28
• Public Version: 3
• Public Version Date: 2020-03-18
• Public Version Status: Update
• Public Device Record Key: a1c50799-6e77-4477-83cb-7135d68a8e0b

Device Description

UV - Tanning lamp

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: Yes
• Has Lot/Batch Number: Yes
• 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
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	04054657500358	GS1
Package	14054657500355	GS1	SecondaryPackaging	1	In Commercial Distribution
Package	54054657600350	GS1	CaseTertiary 100x	100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151674	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry