Duns Number:618214410
Device Description: Lindstrom STAR Manipulator Multi-Directional Cross-Action tip, angled 12mm from bend to ti Lindstrom STAR Manipulator Multi-Directional Cross-Action tip, angled 12mm from bend to tip, round knurled handle, 117mm overall length, Titanium
Catalog Number
E3-2724T
Brand Name
Hayden Medical
Version/Model Number
E3-2724T
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
b0367bd1-98ae-4860-ba3d-d717e85cd83a
Public Version Date
September 20, 2022
Public Version Number
1
DI Record Publish Date
September 12, 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 |