Duns Number:279456896
Device Description: The HYGITECH loupe is an optical instrument developed to facilitate visualisation of speci The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific objects or areas. It was conceived for all precise work as well as helping improve performance of dental surgeons during technical procedures.Characteristics :• A Velcro strap allows comfortable adjustment of the loupe around the head• The loupe can be moved up and down to better align the eyes with the magnified area• The unbreakable lenses protect the eyes, help your eyes adjust quickly and comfortably and give the exact hue of the magnified object• Available in two magnifications, x2.5 or x3.5Ergonomic - Perfectly adjustable around the head, the loupe’s ergonomics offer true comfort and incomparable ease of use.Light- Weighing only 70g, the HYGITECH loupe is remarkably light.Practical- Allowing assistance during technical procedures, the loupe helps give the dental surgeon a better approach to the surgical field
Catalog Number
HY-07104
Brand Name
HYGITECH
Version/Model Number
HY-07104
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
K173062,K173062
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
834cd99a-3ebc-42b0-b96a-3a0f0d69b1d0
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
03615140000185
Quantity per Package
12
Contains DI Package
03615140000178
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 |