Duns Number:190572854
Device Description: FMS neXtra 5.5mm Round Burr Shaver Blades
Catalog Number
283855
Brand Name
FMS NEXTRA
Version/Model Number
283855
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 2021
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
c9e228c3-6695-433e-9e27-75f154827276
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2015
Package DI Number
20886705000231
Quantity per Package
5
Contains DI Package
10886705000234
Package Discontinue Date
January 28, 2021
Package Status
Not 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 |