Duns Number:078383477
Device Description: 25 mm 5 Micron Syringe Filter
Catalog Number
H93821050
Brand Name
SUPOR
Version/Model Number
H93821050
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
d682a329-7011-4f36-bab4-af206b2a0301
Public Version Date
October 11, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
55413765482675
Quantity per Package
50
Contains DI Package
05413765482670
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 30 |