Duns Number:809555139
Device Description: Diamatrix Nucleus Chopper & Safety Quick Chopper, Unique double sided instrument, Diamatri Diamatrix Nucleus Chopper & Safety Quick Chopper, Unique double sided instrument, Diamatrix Nucleus Chopper Curved interior cutting edge with .5mm Olive Shaped tip, Slightly Angled 15mm from bend to tip ~ Safety Quick Chopper, .5mm Olive-Shaped Blade with 1mm bend, Angled 10mm from bend to tip, Intended to be used in the right hand, Round knurled Handle, 143mm total length, Stainless Steel
Catalog Number
H554-R-S
Brand Name
Diamatrix
Version/Model Number
H554-R-S
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
5ef6132b-3e47-42ac-a9ee-3915f145ae09
Public Version Date
February 24, 2022
Public Version Number
1
DI Record Publish Date
February 16, 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 |