Duns Number:544543513
Device Description: 3 ml luer lock disposable syringe without needle.The syringes are intended to inject fluid 3 ml luer lock disposable syringe without needle.The syringes are intended to inject fluids into or withdraw fluids from the body.
Catalog Number
SN01003
Brand Name
CAINA
Version/Model Number
3ML LL-01
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
K113091,K113091,K113091
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
bedcab45-6245-4f8f-afec-fa53e949a977
Public Version Date
February 15, 2021
Public Version Number
1
DI Record Publish Date
February 05, 2021
Package DI Number
16971564465219
Quantity per Package
100
Contains DI Package
06971564465212
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-