Duns Number:097824130
Device Description: The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
Catalog Number
600050-01
Brand Name
TrabEx Pro
Version/Model Number
600050-01
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
Yes
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
K213173
Product Code
MRH
Product Code Name
Pump, Infusion, Ophthalmic
Public Device Record Key
2ba175b4-c8b4-450a-be0a-40eb78eafabe
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 2022
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 | 327 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 535 |