Duns Number:051957769
Catalog Number
-
Brand Name
Member's Mark
Version/Model Number
731365
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
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
08f64962-339c-43db-a613-e0c793bd75e2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 23, 2017
Package DI Number
MHC17313652
Quantity per Package
10
Contains DI Package
MHC17313651
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |