Duns Number:130789944
Device Description: Dornier SingleFlex 400 Laser Fiber - Dornier Direct
Catalog Number
HOL400S
Brand Name
Dornier MedTech
Version/Model Number
400 Micron Single Use
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
7c2634f1-6aac-4959-a842-561dba38d44c
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 10, 2018
Package DI Number
00810116020287
Quantity per Package
3
Contains DI Package
00810116020362
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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 |