Duns Number:407522184
Device Description: DMEK Graft Manipulation Forceps with extra fine tips for intraocular and extraocular unrol DMEK Graft Manipulation Forceps with extra fine tips for intraocular and extraocular unrolling of the graft.
Catalog Number
50.2203
Brand Name
DMEK Graft Manipulation Forceps with extra fine tips
Version/Model Number
50.2203
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
-
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
HNR
Product Code Name
Forceps, Ophthalmic
Public Device Record Key
931824d5-0302-4383-9c9c-b152f9bc8e7a
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
January 29, 2021
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 | 203 |
2 | A medical device with a moderate to high risk that requires special controls. | 149 |