Duns Number:544543513
Device Description: Disposable Needle 23Gx1”.Needles are intended to be used with a legally marketed syringe i Disposable Needle 23Gx1”.Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.
Catalog Number
SN10012
Brand Name
CAINA
Version/Model Number
23G×1
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
62b63247-1a0e-4b1f-b482-621790eabb68
Public Version Date
February 23, 2021
Public Version Number
1
DI Record Publish Date
February 15, 2021
Package DI Number
16971564465271
Quantity per Package
100
Contains DI Package
06971564465274
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-