Duns Number:080113296
Device Description: Pen needle 31G 3/16-5mm
Catalog Number
-
Brand Name
Care Touch
Version/Model Number
PN-313165
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 27, 2017
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
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
766bd1ae-5533-47bd-9974-b50b581893c0
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
00370393000049
Quantity per Package
48
Contains DI Package
00370393102019
Package Discontinue Date
February 27, 2017
Package Status
Not 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. | 5 |