Duns Number:945496792
Device Description: Disposable, single use, surgical Irrigation and Aspiration tubing set
Catalog Number
-
Brand Name
Trabectome Fluidics Set
Version/Model Number
550034-01
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"
Yes
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
-
Product Code
KYG
Product Code Name
Device, Irrigation, Ocular Surgery
Public Device Record Key
afe00e4c-ff2a-4ccb-97bb-a2b783b9725a
Public Version Date
July 25, 2019
Public Version Number
1
DI Record Publish Date
July 17, 2019
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 |