Duns Number:198887072
Device Description: 365 micron Holmium Laser Fiber with SMA 905 connector for Dornier lasers.
Catalog Number
-
Brand Name
MaxiFlex Holmium Laser Fiber
Version/Model Number
MF 400BH D
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013300
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
1cf087b3-7b33-464c-a7f2-c27f6f4a1506
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 24, 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. | 73 |