Duns Number:545570186
Device Description: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection.
Catalog Number
-
Brand Name
Wealy
Version/Model Number
3ml 25Gx1"
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)
-
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
98ad80c6-e423-4939-873e-f4ec58aff6fc
Public Version Date
May 03, 2021
Public Version Number
1
DI Record Publish Date
April 25, 2021
Package DI Number
06971603580531
Quantity per Package
100
Contains DI Package
06971603580500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box