AccessGUDID - DEVICE: COMEG MEDICAL TECHNOLOGIES (03760278260861)

GUDID

Device Identifier (DI) Information

Brand Name: COMEG MEDICAL TECHNOLOGIES
Version or Model: SOPRO 281 LIGHT SOURCE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S81P / 998523
Company Name: SOPRO

Primary DI Number: 03760278260861
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 264205501 *Terms of Use

Device Description: Light Source alone (without Box and accessories) "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
FCW	Light Source, Fiberoptic, Routine

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: 1eb0fe9f-548f-4e7b-ba3d-3ee372b6f807
Public Version Date: December 22, 2021
Public Version Number: 2
DI Record Publish Date: July 16, 2019