Duns Number:190572854
Device Description: FMS OMNICUT Resection Blade 4.2mm SOFT TISSUE and BONE SHAVER BLADE
Catalog Number
283345
Brand Name
FMS OMNICUT
Version/Model Number
283345
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
K130912,K130912
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
1e046d00-ada8-4435-b613-52cc1d2e6945
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2015
Package DI Number
20886705022479
Quantity per Package
5
Contains DI Package
10886705022472
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 |