Duns Number:008124539
Catalog Number
-
Brand Name
Pen Needles
Version/Model Number
7028
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
K131954,K131954,K131954
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
df79e3c4-b006-421e-b025-445482537f6d
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
00616784702834
Quantity per Package
10
Contains DI Package
00616784702827
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |