Duns Number:184763290
Catalog Number
MSSW11/B
Brand Name
Medallion®
Version/Model Number
00884450610343
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
345836ca-3155-4b82-a7f1-c48a3cc34e31
Public Version Date
April 11, 2022
Public Version Number
1
DI Record Publish Date
April 02, 2022
Package DI Number
20884450610347
Quantity per Package
4
Contains DI Package
10884450610340
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |