Duns Number:864213893
Device Description: 3nethra classic camera is a non-mydriatic digital imaging device. It is designed to acquir 3nethra classic camera is a non-mydriatic digital imaging device. It is designed to acquire, display, store and transmit images of the posterior and anterior surfaces of the human eye.
Catalog Number
-
Brand Name
3nethra
Version/Model Number
Classic camera
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PJZ
Product Code Name
Camera, Ophthalmic, General-Use
Public Device Record Key
1419d6d2-a7e1-4fd8-90ca-f95601dff680
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 14, 2016
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 |