AccessGUDID - DEVICE: COMEG MEDICAL TECHNOLOGIES (03760278260045)

GUDID

Device Identifier (DI) Information

Brand Name: COMEG MEDICAL TECHNOLOGIES
Version or Model: UBIPACK ENT SYSTEM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SK101016
Company Name: SOPRO

Primary DI Number: 03760278260045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 264205501 *Terms of Use

Device Description: A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENT UBIPack brings surgeons the perfect all-in-one tool for diagnosis and treatment in an office setting.

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:	Yes
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?
35958	Endoscope video camera	An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	Active	false
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
FWF	Camera, Television, Endoscopic, Without Audio
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: 086813ac-bde5-4f70-94de-a88c218c68e3
Public Version Date: December 22, 2021
Public Version Number: 5
DI Record Publish Date: December 19, 2017