AccessGUDID - DEVICE: SYSTEM TWO LED (00816835023752)

GUDID

Device Identifier (DI) Information

Brand Name: SYSTEM TWO LED
Version or Model: SD2C-LCH
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medical Illumination International Inc.

Primary DI Number: 00816835023752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093357739 *Terms of Use

Device Description: SYSTEM TWO LED, SOLO,IL-CR SURGICAL LIGHT

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?
37332	Operating room light system	An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FST	Light, Surgical, Fiberoptic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100388	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: d68ad88c-9206-441c-bb2e-808452234b28
Public Version Date: April 11, 2024
Public Version Number: 3
DI Record Publish Date: October 22, 2021