Duns Number:088514898
Device Description: Needles for use with compatible needle-based injection systems for subcutaneousinjection o Needles for use with compatible needle-based injection systems for subcutaneousinjection of fluid drug products. Single packed, sterile. For single use only.Non-pyrogenic.
Catalog Number
P1400063
Brand Name
Pencylcap needle
Version/Model Number
U1944111
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
29caa12c-f056-4fd7-a13e-051dadb39456
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 19, 2018
Package DI Number
04046964756900
Quantity per Package
12
Contains DI Package
04046964756290
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |