AccessGUDID - DEVICE: ML 830® (00859626006053)

GUDID

Device Identifier (DI) Information

Brand Name: ML 830®
Version or Model: ML-830-01-007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ML-830-01-007
Company Name: MICROLIGHT CORPORATION OF AMERICA

Primary DI Number: 00859626006053
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137829417 *Terms of Use

Device Description: Safety Glasses

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NHN	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4660f45c-082f-4c4f-b3d3-005ec613d587
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 15, 2016