Duns Number:130213366
Device Description: Haag Streit LED Illumination upgrade. Continuous wave & Synchro Flash (for use with Canon Haag Streit LED Illumination upgrade. Continuous wave & Synchro Flash (for use with Canon DSLR cameras only).
Catalog Number
-
Brand Name
Accu-Beam
Version/Model Number
LED-HS-FL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KEG
Product Code Name
Lamps, Microscope
Public Device Record Key
faf79b88-24c9-4133-a353-4bc0f9f30eb8
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
August 28, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 134 |
2 | A medical device with a moderate to high risk that requires special controls. | 303 |