Duns Number:312889060
Device Description: Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, trans Fiber Probe for Percutaneous Laser Ablation, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, SMA 905 connector, PVC protection cap, extension sleeve silver, fiber stop yellow 144mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 2m +/-0,02m, sterile EO, disposable, double packed
Catalog Number
-
Brand Name
NA
Version/Model Number
Fiber Optic for PLA Short yellow
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
7e453a44-a0b7-4673-a0ba-ad1dec101db3
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
January 15, 2019
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 |