Duns Number:279456896
Device Description: Complete article: Autoclavable frame, single use shieldsAnti-fog treatment Vertical inclin Complete article: Autoclavable frame, single use shieldsAnti-fog treatment Vertical inclinationFrame available in 3 colours: white, blue, pinkLight: 22 gramsComfortable frame, it adapts to all face typesHandy: Shields easy to fitPerfect protection: 30cm shield protects the whole faceThe shield assures clear vision, Abrasion and scratch-resistant
Catalog Number
HY-07003
Brand Name
HYGITECH
Version/Model Number
HY-07003
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
58b4e826-5ff5-418e-a55a-5e28309145d9
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
03615140003957
Quantity per Package
12
Contains DI Package
03615140000161
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |