Duns Number:093377724
Device Description: Sharp tip for lifting or removing premacular, epiretinal, and other vitreoretinal membrane Sharp tip for lifting or removing premacular, epiretinal, and other vitreoretinal membranes.
Catalog Number
7623
Brand Name
Vitreoretinal Micropick
Version/Model Number
7623
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
82975e12-9216-468c-a6b6-9a9865772a0a
Public Version Date
May 12, 2020
Public Version Number
1
DI Record Publish Date
May 04, 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 |