Duns Number:312889060
Device Description: Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with Radial Emission Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with length marking, standard SMA905 connector with knurl nut, PVC protection cap, extension sleeve red engraved, black bend protection, LUER adapter, distal conical tip with silica capillary dome, capillary OD 1000µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed
Catalog Number
-
Brand Name
NA
Version/Model Number
Radial Emission Fiber 400µm
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
K140470
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
fe1fdc99-7348-41b1-9d1d-6af87073070f
Public Version Date
August 17, 2021
Public Version Number
6
DI Record Publish Date
February 18, 2017
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. | 29 |