Duns Number:738574953
Device Description: 532nm adaptor for Keeler Vantage Plus Indirect Ophthalmoscope (100µ)
Catalog Number
-
Brand Name
532nm adaptor for Keeler Vantage Plus IO (100µ)
Version/Model Number
810532IOVPST
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
-
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
b8bb34c2-2dc2-4315-891a-576682c6f02a
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 23, 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. | 55 |