Duns Number:530079367
Device Description: YI XIN Sterile Syringe For Single Use, with needle is intended to be used for medical purp YI XIN Sterile Syringe For Single Use, with needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from the body.
Catalog Number
-
Brand Name
YI XIN Sterile Syringe For Single Use
Version/Model Number
Two-piece 10mL
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"
-
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
K050999,K050999,K050999
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
abde0428-33fc-4ba7-b38f-0ab3674b6419
Public Version Date
October 07, 2019
Public Version Number
2
DI Record Publish Date
September 25, 2019
Package DI Number
16945060500057
Quantity per Package
100
Contains DI Package
06945060500050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-