Duns Number:545570186
Device Description: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto- Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases corss-infection.
Catalog Number
-
Brand Name
Wealy
Version/Model Number
1ml 25Gx5/8"
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141640,K141640,K141640
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
ef28fbbc-5bfc-4d49-882a-66ca536e6a12
Public Version Date
January 05, 2021
Public Version Number
1
DI Record Publish Date
December 28, 2020
Package DI Number
06971603580357
Quantity per Package
100
Contains DI Package
06971603580302
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box