Duns Number:600850213
Device Description: Fibernex 550 micrometer Single Use Holmium Laser Fiber
Catalog Number
-
Brand Name
Fibernex
Version/Model Number
LF0101X550
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
K050738,K050738
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
86a04fae-e2a1-4d4c-8804-2056982f1e60
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 27, 2016
Package DI Number
B0505LF0101X5503
Quantity per Package
5
Contains DI Package
B050LF0101X5500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |