Duns Number:279456896
Device Description: Comprehensive examination kit: a ready-to-use tray for all kinds of proceduresContents: 1 Comprehensive examination kit: a ready-to-use tray for all kinds of proceduresContents: 1 mouth mirror, 1 probe, 1 pair of tweezers, 1 ear-loop mask, 1 tissue, 2 cotton rolls, 1 spatula, 1 saliva pump.
Catalog Number
HY-130025
Brand Name
HYGITECH
Version/Model Number
HY-130025
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
6b9502c0-5ea4-44f3-9303-630cbb34c153
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
December 15, 2020
Package DI Number
03615140002608
Quantity per Package
10
Contains DI Package
03615140002592
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 |