Duns Number:879144426
Device Description: A 4 mm beveled tip infusion cannula used as an aid for infusing fluid into the posterior c A 4 mm beveled tip infusion cannula used as an aid for infusing fluid into the posterior chamber of the eye, and is particularly designed for use with high-viscosity fluids. The flanged cannula is designed to easily suture into place and is qualified for use at operating pressures of up to 70 psi. Sterile, Single Use
Catalog Number
TR9849-51
Brand Name
Viscous Fluid Cannula
Version/Model Number
9849-51
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
-
Product Code
HMX
Product Code Name
Cannula, Ophthalmic
Public Device Record Key
46dabb33-1db1-4397-9939-dd43601ab423
Public Version Date
October 29, 2021
Public Version Number
4
DI Record Publish Date
January 14, 2016
Package DI Number
10853480006164
Quantity per Package
3
Contains DI Package
00853480006167
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |