Duns Number:279456896
Device Description: The infusion stand is ideal for irrigation during implant surgery. Manual height adjustmen The infusion stand is ideal for irrigation during implant surgery. Manual height adjustment: max 2 meters More infoTotal diameter: 30 mmWheelbase: 52 cmMaximum load per hook: 6kg2 year warrantyMade in France
Catalog Number
HY-90070
Brand Name
HYGITECH
Version/Model Number
HY-90070
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
-
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
GFJ
Product Code Name
Mallet, Surgical, General & Plastic Surgery
Public Device Record Key
c74ba0ce-2b15-4df5-9e3c-f52374b2931f
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |