Duns Number:864213893
Device Description: The 3nethra aberro is a handheld autorefractometer equipped with the Shack-Hartmann Wave F The 3nethra aberro is a handheld autorefractometer equipped with the Shack-Hartmann Wave Front Sensor Aberrometry technology to detect visual acuity and refractive errors of the human eye.
Catalog Number
-
Brand Name
3nethra
Version/Model Number
aberro
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
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
640cb76d-1097-434d-b962-7266e7467e72
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
November 04, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |