Duns Number:370193559
Device Description: K-Pack II Needle
Catalog Number
KN-2713RKT50
Brand Name
K-Pack II
Version/Model Number
KN-2713RKT50
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
K110850,K110850,K110850
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
c82b421f-5c65-42c6-8d28-2b2dd23a0d84
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
May 07, 2018
Package DI Number
55413206223645
Quantity per Package
50
Contains DI Package
35413206223641
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 47 |