Duns Number:618214410
Device Description: Machat/Fukasaku PRK/LASIK Spatula 2mm x 5mm ''Hockey Stick'' Shaped Blade with Semi-Sharp Machat/Fukasaku PRK/LASIK Spatula 2mm x 5mm ''Hockey Stick'' Shaped Blade with Semi-Sharp outer edges, round knurled handle, 119mm overall length, stainless steel
Catalog Number
E3-2704
Brand Name
Hayden Medical
Version/Model Number
E3-2704
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
HNN
Product Code Name
Knife, ophthalmic
Public Device Record Key
45cd97a3-be04-4fcf-b471-efffa717feb8
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 |