Duns Number:544543513
Device Description: 3 ml luer lock syringe with needle 25Gx1.The syringes are intended to inject fluids into o 3 ml luer lock syringe with needle 25Gx1.The syringes are intended to inject fluids into or withdraw fluids from the body.
Catalog Number
SNL32510
Brand Name
CAINA
Version/Model Number
3ML LL 25GX1
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
f0f38fb4-09ac-4bba-b84b-fb5e78afcd04
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 10, 2021
Package DI Number
16971564465318
Quantity per Package
100
Contains DI Package
06971564465311
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-