AccessGUDID - DEVICE: GlobTek (00859626006121)

GUDID

Device Identifier (DI) Information

Brand Name: GlobTek
Version or Model: ML-830-02-004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ML-830-02-004
Company Name: MICROLIGHT CORPORATION OF AMERICA

Primary DI Number: 00859626006121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137829417 *Terms of Use

Device Description: Transformer with Output Cord

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?
36800	Isolation transformer	A device designed to be used in a mains electricity alternating current (AC) circuit to increase (step-up) or decrease (step-down) voltage, to provide the specified voltage to a parent device; it is not a built-in component of the parent device. It provides isolation between the mains current and the parent device for safety, and has separate primary (input) and secondary (output) coils.	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: d3493557-09da-4e2b-aaf1-754d4735b27e
Public Version Date: June 08, 2021
Public Version Number: 4
DI Record Publish Date: August 15, 2016