Duns Number:279456896
Device Description: Total protection of the face, eyes and foreheadElastic 3 ply mask with nose clip, EN 14683 Total protection of the face, eyes and foreheadElastic 3 ply mask with nose clip, EN 14683Fully transparent panoramic visorNo glass fibres, latex-free, odourless .Comfortable: flexible nose piece sheathed steel 9cm High strength visor stitched to the maskAnti-fog treatment on the inside and front of the shieldDoesn't affect vision during procedurePerfect protection: 30cm wrap-around visorLightweight: 11gCan be worn with precription glassesPacked individually keeping the visors in perfect condition
Catalog Number
HY-07011
Brand Name
HYGITECH
Version/Model Number
HY-07011
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
Yes
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
669f185a-26e1-4b54-8452-e815151d1d04
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 2020
Package DI Number
03615140000413
Quantity per Package
18
Contains DI Package
03615140000406
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 |