AccessGUDID - DEVICE: COMEG MEDICAL (M430S28100011)

GUDID

Device Identifier (DI) Information

Brand Name: COMEG MEDICAL
Version or Model: SOURCE LED SOPRO 281 ORL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S_281_0001
Company Name: SOPRO

Primary DI Number: M430S28100011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 264205501 *Terms of Use

Device Description: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices of the following special fields: ent, gynecology, urology, veterinary. It is equipped with an electronic iris with fibre optic sensor, an automatic thermal protection system and a power level memory."

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?
35158	Endoscopic light source unit, line-powered	A mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTN	Led Light Source

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103813	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: e8cc90f4-9274-4402-9a63-8789d01e281b
Public Version Date: December 22, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016