Duns Number:260069352
Device Description: Disposable needle for hypodermic injections
Catalog Number
KIPIC27G13
Brand Name
KIPIC® Sterile hypodermic needle for single use
Version/Model Number
27G x 13 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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
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
6325fdc7-bee3-4578-a522-317b54d6bce0
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
November 30, 2019
Package DI Number
03760173230327
Quantity per Package
10000
Contains DI Package
03760173230310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 92 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |