Duns Number:315304071
Device Description: ARTHRO IRRIGATION PUMP 150MMHG for arthroscopy , for fluid management of irrigation fluid ARTHRO IRRIGATION PUMP 150MMHG for arthroscopy , for fluid management of irrigation fluid in joints, with instrument recognition, LCD Display, compatible with core, connection for footswitch and remote control, max. flushing performance 1.5l/min, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 330x155x390mm
Catalog Number
2203.002
Brand Name
FLUID CONTROL
Version/Model Number
2203002
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
c6fea15e-a437-4b9a-b560-bccc763b2855
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
July 21, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |