HYGITECH - The HYGITECH loupe is an optical instrument - HYGITECH

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

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More Product Details

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

Product Characteristics

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 Details

Product Code

FXX

Product Code Name

Mask, Surgical

Device Record Status

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

Additional Identifiers

Package DI Number

03615140000185

Quantity per Package

12

Contains DI Package

03615140000178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"HYGITECH" Characteristics
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