Duns Number:279456896
Device Description: Ideal for short procedures or simple patient visits.Packed in a transparent plastic peel p Ideal for short procedures or simple patient visits.Packed in a transparent plastic peel pack tray, which provides easy identification of contents.Contents: 1 mouth mirror, 1 probe, 1 pair of tweezers.
Catalog Number
HY-130012
Brand Name
HYGITECH
Version/Model Number
HY-130012
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
KDD
Product Code Name
Kit, Surgical Instrument, Disposable
Public Device Record Key
6defeaf5-367b-4441-aac6-6b12e0d4d825
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
November 24, 2020
Package DI Number
03615140002578
Quantity per Package
20
Contains DI Package
03615140002561
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 |