AccessGUDID - DEVICE: ML 830® (00859626006312)

GUDID

Device Identifier (DI) Information

Brand Name: ML 830®
Version or Model: ML-830-07-007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ML-830-07-007
Company Name: MICROLIGHT CORPORATION OF AMERICA

Primary DI Number: 00859626006312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137829417 *Terms of Use

Device Description: SL Triple Probe Holder

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?
41707	Laser beam delivery unit holder	A device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device.	Active	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: 1b8c39ff-7b24-4da4-ba8a-304c3e423920
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 15, 2016