Duns Number:264205501
Device Description: A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENTUBIPack brings surgeons th A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENTUBIPack brings surgeons the perfect all-in-one tool for diagnosis and treatment in an office setting.
Catalog Number
SK101016
Brand Name
COMEG MEDICAL TECHNOLOGIES
Version/Model Number
UBIPACK ENT SYSTEM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103813
Product Code
FCW
Product Code Name
Light Source, Fiberoptic, Routine
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |