Duns Number:023904428
Device Description: SYRINGE/NDL, SAFETY 3CC 25GX5/8" (HINGED STYLE)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-SN3C2558S
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
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
91708a7b-2059-45c1-9190-124cef2e00a5
Public Version Date
December 02, 2019
Public Version Number
1
DI Record Publish Date
November 22, 2019
Package DI Number
40612479244618
Quantity per Package
8
Contains DI Package
20612479244607
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 |