Duns Number:279456896
Device Description: Bridge tables simplify the work in the operating theatre. The drape-covered table is posit Bridge tables simplify the work in the operating theatre. The drape-covered table is positioned over the patient and carries the instruments needed for the operation.Built in durable, shiny stainless steel, HYGITECH Bridge table has a wide and solid tray, which enables the dentist to have all the materials he needs for the surgery at hand.The edges of the table have no lip, allowing the surgeon to grasp instruments easily.Dimensions of the table tray: 60 x 90 cmAdjustable height: from 90 cm to 180 cmWeight: 15 kg
Catalog Number
HY-90010
Brand Name
HYGITECH
Version/Model Number
HY-90010
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
249f676f-5fdd-4c65-ab20-9a97b9308820
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 |