Duns Number:008171162
Device Description: Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneo Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.
Catalog Number
-
Brand Name
Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's
Version/Model Number
278030
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161950,K161950
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
3a47c013-8a9e-45cb-a356-056442e4edf0
Public Version Date
January 22, 2020
Public Version Number
1
DI Record Publish Date
January 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |