Duns Number:482661753
Device Description: FMS Mini Full Radius Blade Plus 2.7mm
Catalog Number
283209
Brand Name
FMS
Version/Model Number
283209
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
fdd7b43e-4180-4811-b599-25fe01e60417
Public Version Date
July 04, 2022
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
20886705027184
Quantity per Package
5
Contains DI Package
10886705027187
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 | 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 |