Duns Number:043081723
Device Description: Syringes single-use sterile 30 gauge .5 cc 5/16" needle Sleeve of 10
Catalog Number
605S
Brand Name
Advocate Syringes .5 cc 30 G 5/16" needle
Version/Model Number
605
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
4c7e8227-eeb9-4a22-babb-d22bfb4d3fde
Public Version Date
November 01, 2022
Public Version Number
5
DI Record Publish Date
August 14, 2019
Package DI Number
00894046001646
Quantity per Package
10
Contains DI Package
00894046001790
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
606 Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |