Duns Number:279456896
Device Description: Hydraulic mayo table with swivelHYGITECHReference: HY-90021The Mayo table is positioned ri Hydraulic mayo table with swivelHYGITECHReference: HY-90021The Mayo table is positioned right next to the surgeon and supports the implantology engine. The ideal companion of the practitioner, the Mayo hydraulic table meets two objectives:- Improvement of the firm's organization - Considerable time savingTwo important points that guarantee optimal comfort during surgery
Catalog Number
HY-90021
Brand Name
HYGITECH
Version/Model Number
HY-90021
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
FXP
Product Code Name
Cover, Shoe, Operating-Room
Public Device Record Key
e35c07b2-7693-4f4d-b24a-8635214f3c87
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 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 |