Duns Number:190572854
Device Description: FMS Fluid Management System 4.5mm FMS Outflow Cannula
Catalog Number
281580
Brand Name
FMS
Version/Model Number
281580
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
HNX
Product Code Name
Depressor, orbital
Public Device Record Key
ece83739-e1ec-47a2-be78-65996c47d650
Public Version Date
August 30, 2021
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
20886705016331
Quantity per Package
20
Contains DI Package
10886705016334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |