Duns Number:618214410
Device Description: Nucleus Chopper & Safety Quick Chopper DBL-Ended, curved interior cutting edge with .5mm o Nucleus Chopper & Safety Quick Chopper DBL-Ended, 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, for use in the...
Catalog Number
E3-2006
Brand Name
Hayden Medical
Version/Model Number
E3-2006
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
HND
Product Code Name
Spatula, ophthalmic
Public Device Record Key
1e274061-2c4e-428e-b8e4-bf5ffc85a657
Public Version Date
August 24, 2022
Public Version Number
1
DI Record Publish Date
August 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 | 2893 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |