Duns Number:279456896
Device Description: Visit kitHYGITECHReference: HY-03811The VISIT kit is specifically designed for short denta Visit kitHYGITECHReference: HY-03811The VISIT kit is specifically designed for short dental procedures. It contains comprehensive protective clothing for either the surgeon, the assistant or the patient. It is composed of 10 items.More info1 Bouffant cap1 Surgical hat1 Tie-on mask3 Paper hand-towels1 Surgical gown with cotton cuffs1 Pair of overshoes1 Wrapping pape
Catalog Number
HY-03811
Brand Name
HYGITECH
Version/Model Number
HY-03811
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
f65001fc-65e1-4ff4-872e-488c8432f8a9
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
Package DI Number
03615140005319
Quantity per Package
20
Contains DI Package
03615140005326
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 |