Duns Number:945496792
Device Description: The Trabectome High Frequency Generator (110V) is used with compatible electrosurgical ins The Trabectome High Frequency Generator (110V) is used with compatible electrosurgical instruments for low power microsurgical applications for the removal, destruction and coagulation of tissue.
Catalog Number
550047-01
Brand Name
Trabectome High Frequency Generator (110V)
Version/Model Number
550047
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
dc8f243c-2626-449d-be50-a96d43c94be2
Public Version Date
December 16, 2019
Public Version Number
4
DI Record Publish Date
September 28, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |