Duns Number:430899318
Device Description: G.o.c.c.l.e.s light represents the proprietary light source to be used with G.o.c.c.l.e.s G.o.c.c.l.e.s light represents the proprietary light source to be used with G.o.c.c.l.e.s eyewear in order to allow the illumination of the oral cavity during oral examination, characterized by an excitation band from 440 to 490 nm.
Catalog Number
531000611
Brand Name
G.o.c.c.l.e.s. light
Version/Model Number
G.o.c.c.l.e.s. light
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
f16c7131-2782-40d3-b6ed-fc65e3a5f587
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 |