Duns Number:007914906
Device Description: 6mm Pen Needle Box
Catalog Number
-
Brand Name
Good Neighbor Pharmacy
Version/Model Number
10144900
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
K100812,K152410,K100812,K152410,K100812,K152410
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
f7ac5e86-ae96-4a94-abbe-4d1a7d6802ae
Public Version Date
August 08, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
20087701426432
Quantity per Package
12
Contains DI Package
00087701426438
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |