Duns Number:809555139
Device Description: Ernest Nucleus Cracker, 2.0mm paddle tips with serrations for maximum grip, Three Hole Cro Ernest Nucleus Cracker, 2.0mm paddle tips with serrations for maximum grip, Three Hole Cross-Action Handle, 100mm total length, Stainless
Catalog Number
F724S-.25
Brand Name
Diamatrix
Version/Model Number
F724S-.2
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
4d371a96-c558-41d3-b52f-75329d1bfbb5
Public Version Date
April 13, 2021
Public Version Number
1
DI Record Publish Date
April 05, 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 | 475 |
U | Unclassified | 13 |