Duns Number:312889060
Device Description: Corona 360 Fiber, core 550µm, clad 578µm, fiber OD 1400µm, white Vestodur Jacket with leng Corona 360 Fiber, core 550µm, clad 578µm, fiber OD 1400µm, white Vestodur Jacket with length marking, customized connector, white bend protection, distal conical tip with silica capillary dome, capillary OD 1800µm, NA 0.22, length 2,6m +/-0,2m, sterile EO, disposable, double packed
Catalog Number
-
Brand Name
NA
Version/Model Number
Corona 360 Fiber 600µm
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
df82e58b-9db4-4f7e-a0bf-873d207be555
Public Version Date
April 07, 2021
Public Version Number
5
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 |