Duns Number:544543513
Device Description: The Syringe with permanently attached needle is intended for use by health care profession The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
Catalog Number
SPN102510
Brand Name
CAINA
Version/Model Number
1ml 25G*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
K192551,K192551,K192551
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
3f25599e-bb6a-4eb3-89f5-9a1717c135ac
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 19, 2021
Package DI Number
16971564465615
Quantity per Package
100
Contains DI Package
06971564465618
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-