Duns Number:279456896
Device Description: Protective glasses for both the dentist and the patient, ideal during polymerisation of de Protective glasses for both the dentist and the patient, ideal during polymerisation of dental pulp.• Perfect protection: protects against splashes, UV rays (efficient against the UVC) and blue light, improves contrast and reduces eye fatigue• Full lateral protection• Single-piece frame for the best eye protection• Can be worn alone or over glasses.• Anti-fog and anti-scratch treatment on the inside and front of glasses• Provides comfort during procedures : doesn’t affect vision during a procedure• Dimensions: 19cm width x 7cm height• Light weight: 36 g
Catalog Number
HY-07015
Brand Name
HYGITECH
Version/Model Number
HY-07015
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HOY
Product Code Name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Public Device Record Key
99797730-8bde-4207-a0a7-e32914914924
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140000390
Quantity per Package
100
Contains DI Package
03615140000383
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |