Duns Number:093377724
Device Description: Atraumatic entry through existing tears or holes for aspiration of subretinal fluid. Tip L Atraumatic entry through existing tears or holes for aspiration of subretinal fluid. Tip Length 3mm.
Catalog Number
7823
Brand Name
Subretinal Fluid Cannula
Version/Model Number
7823
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
d0436197-ff4a-4f51-b976-486cb0b8bf1d
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 2020
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 | 75 |