AccessGUDID - DEVICE: Sunoptic Technologies (M678TX0)

GUDID

Device Identifier (DI) Information

Brand Name: Sunoptic Technologies
Version or Model: Tx series Xenon Lightsource
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNOPTIC TECHNOLOGIES LLC

Primary DI Number: M678TX0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094586898 *Terms of Use

Device Description: Tx series Xenon Lightsource

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?
32037	General-purpose light source	A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSS	Light, Surgical, Floor Standing
FCR	Light Source, Photographic, Fiberoptic
FCW	Light Source, Fiberoptic, Routine
HBI	Illuminator, Fiberoptic, Surgical Field
HET	Laparoscope, Gynecologic (And Accessories)

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: db153b01-d736-476f-9acb-e128a7ee8dbc
Public Version Date: March 12, 2025
Public Version Number: 5
DI Record Publish Date: May 09, 2017