Duns Number:187502109
Device Description: Arthroscopy Pump, Fluid Management System, Do not use if package is damaged, Keep dry, Kee Arthroscopy Pump, Fluid Management System, Do not use if package is damaged, Keep dry, Keep away from sunlight, Protect from heat and radioactive sources.
Catalog Number
0350-202-000
Brand Name
FloControl, Fluid Safe
Version/Model Number
0350202000
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
-
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
b01db2ee-15c9-48d4-9e8f-a0e2e31cc2ce
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
37613327061711
Quantity per Package
10
Contains DI Package
07613327061710
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |