Duns Number:809555139
Device Description: Koch Spatula and Nagahara Chopper, Unique double sided instrument, Koch spatula, .8mm Wide Koch Spatula and Nagahara Chopper, Unique double sided instrument, Koch spatula, .8mm Wide Gently curved shaft with Duckbill-shaped tip, / Nagahara Chopper, 1.5mm - The cutting edge is offset 60* to cut toward phaco tip, Angled 10mm from bend to tip, Round knurled Handle, 126mm total length, Diamatrix Signature Featherweight Handle
Catalog Number
H574-D
Brand Name
Diamatrix
Version/Model Number
H574-D
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
HNQ
Product Code Name
Hook, Ophthalmic
Public Device Record Key
7acb8487-4258-4238-bfd3-b32c3631cd2e
Public Version Date
October 14, 2020
Public Version Number
1
DI Record Publish Date
October 06, 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 | 475 |
| U | Unclassified | 13 |