Duns Number:544543513
Device Description: Syringe with safety needle 3ml LL 21G*1.The Syringe with Safety Needle is intended for use Syringe with safety needle 3ml LL 21G*1.The Syringe with Safety Needle is intended for use in the 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 syringe with safety needle contained in a sterility maintenance package.
Catalog Number
CA3215
Brand Name
CAINA
Version/Model Number
3ml LL 21G*1-01
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
K193526,K193526,K193526
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
f3087bd1-3b1d-4d8f-837b-692440f04723
Public Version Date
November 18, 2020
Public Version Number
1
DI Record Publish Date
November 10, 2020
Package DI Number
16971564465127
Quantity per Package
100
Contains DI Package
06971564465120
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-