Duns Number:544543513
Device Description: Safety needle 21Gx1.5".The Safety Needle is intended for use with a luer lock syringe for Safety needle 21Gx1.5".The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.The safety needle contained in a sterility maintenance package.
Catalog Number
CN2115
Brand Name
CAINA
Version/Model Number
21Gx1.5-02
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
K193526,K193526,K193526
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
2c060764-68ba-4b6d-9e09-40a242996727
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 10, 2021
Package DI Number
16971564465370
Quantity per Package
100
Contains DI Package
06971564465373
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-