Duns Number:389567538
Device Description: 550 Micron 5X Reusable Lightguide, 150 watt, bare fiber tip, 3.5 meter length, 0.78 mm out 550 Micron 5X Reusable Lightguide, 150 watt, bare fiber tip, 3.5 meter length, 0.78 mm outer diameter
Catalog Number
K2012439
Brand Name
Dornier MedTech
Version/Model Number
550 Micron 5X Reusable
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
K991183
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
c30671c4-bc88-4c18-88db-e7823d309549
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 11, 2018
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. | 28 |