Duns Number:483267576
Device Description: TranCanula is a single-use irrigation cannula for washing the anterior chamber of the eye,
Catalog Number
-
Brand Name
Tran Canula
Version/Model Number
TC01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HMX
Product Code Name
Cannula, Ophthalmic
Public Device Record Key
14df41e6-9718-4f99-ad71-801ae68136fb
Public Version Date
October 07, 2019
Public Version Number
3
DI Record Publish Date
May 23, 2019
Package DI Number
EFABTC011
Quantity per Package
5
Contains DI Package
EFABTC012
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |