Duns Number:023904428
Device Description: SYRINGE/NDL, SAFETY 3CC 23GX1"
Catalog Number
-
Brand Name
McKesson
Version/Model Number
102-SN3C231S
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
K051865,K051865,K051865
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
cf9ebb51-007e-49b3-ac4e-1743662cf38f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
30612479179067
Quantity per Package
100
Contains DI Package
20612479179053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
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 |