Duns Number:314482980
Catalog Number
21702-04C
Brand Name
Multiple Brainmets Srs
Version/Model Number
1.5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 10, 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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142108,K170750
Product Code
MUJ
Product Code Name
System,Planning,Radiation Therapy Treatment
Public Device Record Key
fba7c60d-7d17-4178-b511-71079137f8c6
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
February 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 48 |
2 | A medical device with a moderate to high risk that requires special controls. | 685 |