Duns Number:187502109
Device Description: [Arthroscopy Pump, Do not use if package is damaged, Keep dry, Keep away from sunlight, [Arthroscopy Pump, Do not use if package is damaged, Keep dry, Keep away from sunlight, Protect from heat and radioactive sources.]
Catalog Number
0350-800-006
Brand Name
FloSteady
Version/Model Number
0350800006
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
05f3edb3-ef65-40af-b656-e692786baf39
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
37613327061681
Quantity per Package
10
Contains DI Package
07613327061680
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 |