Duns Number:008171162
Device Description: Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcuta Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Catalog Number
-
Brand Name
Assure® ID Safety Pen Needle 5mm x 31g 100's
Version/Model Number
275131
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,K161950
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
a40874f1-9a1b-4773-bbe5-a3753db9dd94
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 08, 2018
Package DI Number
10015482275317
Quantity per Package
12
Contains DI Package
00015482275310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Case
| 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 |