AccessGUDID - DEVICE: MI Product Line (00816835020133)

GUDID

Device Identifier (DI) Information

Brand Name: MI Product Line
Version or Model: 061413B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medical Illumination International Inc.

Primary DI Number: 00816835020133
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093357739 *Terms of Use

Device Description: MI-750 Minor Surgical Light, Floor Stand with Battery Back-up

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):	No
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?
36843	Mobile examination/treatment room light	A mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSY	Light, Surgical, Ceiling Mounted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140812	000

Device Exempt from Premarket Submission: No 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: 6a920d16-1700-4fc2-b0f6-b0f04f270031
Public Version Date: April 10, 2024
Public Version Number: 9
DI Record Publish Date: September 23, 2016