Duns Number:051957769
Device Description: Sterile, single use pen needles.Intended to be used with pen injector device for the subcu Sterile, single use pen needles.Intended to be used with pen injector device for the subcutaneous injection of insulin.
Catalog Number
8931
Brand Name
Member's Mark pen needles 31G 5mm
Version/Model Number
31G x 5 mm
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)
-
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
6bfd8eeb-2371-4e1b-948b-781d2ab885d6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 06, 2017
Package DI Number
20078742257734
Quantity per Package
30
Contains DI Package
00078742257730
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |