Duns Number:267476323
Device Description: Pressure Injectable Safety Huber Needle
Catalog Number
-
Brand Name
PPS PI
Version/Model Number
U202014
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K120261,K120261
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
482570b6-2776-4922-9d0e-d7734444fc27
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
13661234011275
Quantity per Package
12
Contains DI Package
03661234011278
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 98 |