Duns Number:279456896
Device Description: Mayo tables are positioned right next to the surgeon and carry the implant motor. They can Mayo tables are positioned right next to the surgeon and carry the implant motor. They can also be positioned over the patient, with the ability to be placed from one side only. HYGITECH Mayo table is built from durable, shiny stainless steel.The edges of the table have no lip, to allow the tubes coming from the motor to hang freely.• Tray dimensions: 73 cm x 47 cm x 3 cm • Dimensions between wheels: 36 cm front wheels, 32 cm rear wheels• Height (including wheels): 74.5cm• Adjustable height: from 74.5 cm to 117 cm• Weight: 13 kg
Catalog Number
HY-90016
Brand Name
HYGITECH
Version/Model Number
HY-90016
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
LYU
Product Code Name
Accessory, Surgical Apparel
Public Device Record Key
33f58d4c-771d-4779-ba7d-b401716f363e
Public Version Date
December 23, 2020
Public Version Number
1
DI Record Publish Date
December 15, 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 |