Duns Number:713383495
Device Description: The MW50D LED SLIT LAMPs are designed for ophthalmic observation and microphotography. The The MW50D LED SLIT LAMPs are designed for ophthalmic observation and microphotography. These slit lamps feature 5 step magnification microscopes that can be used for ophthalmic observation.Consisting of;・LED Slit Lamp MW50D Main Body ・Eyepiece 12.5X for MW50・Eyepiece 12.5X for MW50・Wooden Table top with Chin rest for MW50・Power supply Unit for MW50D・Power supply Cord Hospital Grade(120V)・Dust Cover (No Logo Mark)・Imaging Unit for S4OPTIK MW50・S4OPTIK MW File
Catalog Number
-
Brand Name
LED SLIT LAMP
Version/Model Number
MW50D
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
K110129
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
44ee9f5c-255d-4520-b386-8f86c941db4a
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
November 14, 2018
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 |