Duns Number:332599307
Device Description: MatriXX Evolution kalibriert
Catalog Number
-
Brand Name
MatriXX Evolution kalibriert
Version/Model Number
E3030012
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072374,K072374
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
ced7d872-3aa7-4a55-acd3-30f0870cde68
Public Version Date
August 10, 2020
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
EIBAE30300121
Quantity per Package
1
Contains DI Package
EIBAE30300120
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Aluminium case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |