Spectroline

Basic Information

• Brand Name: Spectroline
• Primary DI: 00672052155276
• Version / Model: Q-12
• Catalog Number: 102
• Company Name: SPECTRONICS CORPORATION
• Labeler DUNS: 002044410
• 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: 1faea73f-88ec-4229-82b2-145446dc873f

Device Description

Two 4-Watt Integrally Filtered UV-A Tubes Woods Lamp

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	878.4630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36941	Wood's lamp	A light designed to emit ultraviolet light (at a wavelength of approximately 365 nm) to illuminate parts of the body to observe fluorescence for diagnostic purposes. It is typically used to help diagnose dermal fungal infections (e.g., Microsporum audouini), bacterial infections (e.g., Corynebacterium minutissimum, Pseudomonas), parasitic infections (e.g., scabies), and pigmentary disorders (e.g., vitiligo). It also often used to examine rape victims for sperm residues or examine a patient's eyes for corneal lesions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00672052155276	GS1