Duns Number:279456896
Device Description: BASICS Set 3 instrumentsHYGITECHReference: HY-130014The most popular 3 instrument set is b BASICS Set 3 instrumentsHYGITECHReference: HY-130014The most popular 3 instrument set is back in an even more economical version!Packaged with 400 pieces, it allows you to make substantial savingsIdeal for short procedures or control visits. Packaged in a paper/transparent plastic film for quick identification of the contents.Includes:1 mirror with a mixing spatula1 tweezer1 double probeThat's a total of 5 instruments!
Catalog Number
HY-130014
Brand Name
HYGITECH
Version/Model Number
HY-130014
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
ECP
Product Code Name
Instrument, Ligature Tucking, Orthodontic
Public Device Record Key
8c3157bc-f29c-4b2f-8e4b-3cbf87340500
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
December 16, 2020
Package DI Number
03615140004527
Quantity per Package
400
Contains DI Package
03615140004534
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 |