Duns Number:421141183
Device Description: 31G 8mm, 100pcs
Catalog Number
18-3108
Brand Name
Easydrip Insulin Penneedle
Version/Model Number
18-3108
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)
-
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
66d13352-8b83-43f0-841b-bf022ddcf995
Public Version Date
May 18, 2020
Public Version Number
2
DI Record Publish Date
May 03, 2018
Package DI Number
26945630104378
Quantity per Package
20
Contains DI Package
16945630104371
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. | 19 |