Duns Number:023904428
Device Description: Syringes with Safety Hypodermic Needles GLIDE 1cc 25G x 5/8 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
192-SN1C2558S
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
K980580,K951254,K951254,K980580,K980580,K951254
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
c3a4bc6a-adca-4888-b1b8-cc9d2151a4e6
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
October 03, 2019
Package DI Number
40612479248739
Quantity per Package
8
Contains DI Package
20612479248605
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 |