Duns Number:079755637
Device Description: Canaloplasty Microcatheter KitKit Contents:(1) Canaloplasty Microcatheter iTrack 250A(1) O Canaloplasty Microcatheter KitKit Contents:(1) Canaloplasty Microcatheter iTrack 250A(1) Opthalmic Viscoinjector
Catalog Number
200478
Brand Name
iTrack 250A
Version/Model Number
iTrack 250A
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
K050716,K080067
Product Code
HMX
Product Code Name
Cannula, Ophthalmic
Public Device Record Key
099ce6e6-853e-4275-809e-e2c538f9da0b
Public Version Date
December 08, 2020
Public Version Number
6
DI Record Publish Date
September 15, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |