Duns Number:430899318
Device Description: The G.o.c.c.l.e.s device consist of one eyewear with specific filtering features that shal The G.o.c.c.l.e.s device consist of one eyewear with specific filtering features that shall be used with the G.o.c.c.l.e.s. light proprietary light source, in order to allows the examination of autofluorescence of the oral cavity and consequently detect oral abnormalities such as dysplastic or anaplastic lesions (carcinomas of the oral mucosa).
Catalog Number
531000601
Brand Name
G.o.c.c.l.e.s.
Version/Model Number
G.o.c.c.l.e.s.
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151630
Product Code
NXV
Product Code Name
Diagnostic Light, Soft Tissue Detector
Public Device Record Key
e166c533-30e9-4a82-9246-504d6ef2589d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |