Duns Number:690592464
Device Description: The device is used to inject fluids into, or withdraw fluids from, the body.
Catalog Number
-
Brand Name
DISPOSABLE SYRINGE W/O NEEDLE 100mL LL CENTER NOZZLE
Version/Model Number
551721050
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)
Yes
Over the Counter (OTC)
-
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
0920225a-5df7-4deb-a28d-7f6ae1b44f99
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
34987494066262
Quantity per Package
25
Contains DI Package
04987494066261
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box