Duns Number:713383495
Device Description: The NS-2D zoom slit lamps are designed for ophthalmic observation and microphotography. Th The NS-2D zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscope that can be used for ophthalmic observation.consisting of:・Zoom Slit Lamp NS-2D Main Body with Imaging Unit(with Background Light)・Eyepiece 12.5X for NS-2D・Eyepiece 12.5X with Reticle for NS-2D・Wooden Table top with Chin Rest for NS-2D・Power supply for Illumination P-300N・UL Power supply Cord Hospital Grade(120V)・Dust Cover (Righton Logo)・Righton NS File
Catalog Number
-
Brand Name
Zoom Slit Lamp
Version/Model Number
NS-2D
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110129
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
af0520b1-8281-48ad-92f7-a9b9db930a2e
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
July 13, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |