Duns Number:485050483
Device Description: 13 mm Syringe Filter with 17 micron polyester screen designed for rapid filtration and bro 13 mm Syringe Filter with 17 micron polyester screen designed for rapid filtration and broad drug compatibility to assure quality control in drug preparation.
Catalog Number
6074185
Brand Name
Pall® Syringe Filter 13mm, 17 micron polyester screen
Version/Model Number
6074185
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"
Yes
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
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
00324d36-b150-425b-91e9-7a1660912777
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 20, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |