Duns Number:023904428
Device Description: Insulin Syringe with Needle 1cc 29G x ½”
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-SN1C2905
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151949,K151949,K151949
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
124d06bd-1cc0-4798-901a-90d78f1f37d9
Public Version Date
September 21, 2018
Public Version Number
1
DI Record Publish Date
August 21, 2018
Package DI Number
40612479231700
Quantity per Package
5
Contains DI Package
20612479231690
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |