AccessGUDID - DEVICE: Micromed (08033928121207)

GUDID

Device Identifier (DI) Information

Brand Name: Micromed
Version or Model: LED PHOTIC POWER
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICROMED SPA

Primary DI Number: 08033928121207
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 856998166 *Terms of Use

Device Description: LED PHOTIC POWER is the power supply adapter included in LED PHOTIC System. LED PHOTIC System is used for the photic stimulation of the patient during the EEG recording

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):	Yes
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?
37855	Ophthalmic flash generator	A mains electricity (AC-powered), electronic, device that is used to generate an extremely strong flash or series of flashes of bright light that are used as a photostimulation in a parent device, e.g., an electroencephalograph (EEG), an electroretinograph (ERG), or a euthyscope. This device may be known as a flash booster.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWE	Stimulator, Photic, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211974	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: 02d8d5a7-c027-434f-b6f5-6d2162bec8f7
Public Version Date: November 02, 2021
Public Version Number: 1
DI Record Publish Date: October 25, 2021