Duns Number:279456896
Device Description: Single use sterile mirror, 21mm diameter with anti-fog treatment. Handle length: 14 cm.Adv Single use sterile mirror, 21mm diameter with anti-fog treatment. Handle length: 14 cm.Advantages:- Bright and brilliant reflexion: The mirror is made of rhodium, thus the image is reflected only once.- Convenient: Ideal angulation (30°)
Catalog Number
HY-130010
Brand Name
HYGITECH
Version/Model Number
HY-130010
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
-
Product Code
EIY
Product Code Name
Instrument, Filling, Plastic, Dental
Public Device Record Key
1335c0be-d6d2-4698-8158-260c621c6cf1
Public Version Date
December 15, 2020
Public Version Number
2
DI Record Publish Date
November 24, 2020
Package DI Number
03615140002769
Quantity per Package
20
Contains DI Package
03615140002752
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 |