Duns Number:130789944
Device Description: Dornier SingleFlex 1000 High Energy Laser Fiber - Dornier Direct
Catalog Number
HOL1000SHE
Brand Name
Dornier MedTech
Version/Model Number
1000 Micron Single Use HE
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
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
K121938,K121938
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
5e09e446-4073-47f6-9640-160f437e5bc8
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
October 16, 2019
Package DI Number
00810116020836
Quantity per Package
3
Contains DI Package
00810116020775
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |