ML 830®

Basic Information

• Brand Name: ML 830®
• Primary DI: 00859626006053
• Version / Model: ML-830-01-007
• Catalog Number: ML-830-01-007
• Company Name: MICROLIGHT CORPORATION OF AMERICA
• Labeler DUNS: 137829417
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4660f45c-082f-4c4f-b3d3-005ec613d587

Device Description

Safety Glasses

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
NHN	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38360	Radiation shielding goggles	A personal protective device intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical and dental procedures. It will typically be designed as goggles consisting of a single unit with lenses, side shields, top shields, and bottom shields made from clear lead-equivalent materials, e.g., glass or plastic. The lenses and shields offer additional physical barrier protection from liquid radioactive materials. Goggle lenses may be either uncorrected (non-prescription) or corrected (prescription) for the individual's vision.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859626006053	GS1

Customer Contacts

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