Duns Number:043081723
Device Description: Advocate Syringes for U-100 Insulin 30G .3CC 5/16" Needle, Single Use, Sleeve of 10
Catalog Number
607S
Brand Name
Advocate Syringes for U-100 Insulin 30G .3CC 5/16" Needle
Version/Model Number
607
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
2fc5363b-53fc-41be-9ce0-574f284f8309
Public Version Date
February 07, 2022
Public Version Number
7
DI Record Publish Date
August 20, 2016
Package DI Number
00894046001660
Quantity per Package
10
Contains DI Package
00894046001806
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
608
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |