Duns Number:482661753
Device Description: FMS Fluid Management System Tornado Micro II No-Button Shaver Handpiece Shaver handpiece w FMS Fluid Management System Tornado Micro II No-Button Shaver Handpiece Shaver handpiece without hand control
Catalog Number
283712
Brand Name
FMS
Version/Model Number
283712
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041824,K954465
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
e25fe455-5de6-437f-b03c-3270d709a119
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
June 19, 2020
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |