Duns Number:088514898
Device Description: Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyroge Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.
Catalog Number
16442EMD
Brand Name
Serofine needles 30G
Version/Model Number
U1244119
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 27, 2021
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
9eca24af-737a-4e6b-9693-ffdc81855c3b
Public Version Date
October 28, 2021
Public Version Number
2
DI Record Publish Date
April 11, 2019
Package DI Number
04046963414047
Quantity per Package
12
Contains DI Package
04046963414030
Package Discontinue Date
October 27, 2021
Package Status
Not 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 |