Duns Number:809555139
Device Description: Kershner Capsulorrhexis Forceps, Thin Triangular Grasping tips, Angled 8mm from bend to ti Kershner Capsulorrhexis Forceps, Thin Triangular Grasping tips, Angled 8mm from bend to tip, Diamond knurled handle with Flat, Guide pin stop for tip alignment, 102mm total length, Titanium
Catalog Number
F645T
Brand Name
Diamatrix Ltd
Version/Model Number
F645T
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
7e83715e-dcb1-41a1-8124-b5fdf3ec6df5
Public Version Date
May 25, 2022
Public Version Number
1
DI Record Publish Date
May 17, 2022
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 |