Duns Number:879187821
Device Description: Retractable Safety Syringe 5ML 23G X 1"
Catalog Number
SS5ML23G101
Brand Name
Wealy® RELI®
Version/Model Number
SS5ML23G101
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
K113587,K113587,K113587
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
527f644b-9ff5-40b7-9678-240d606e864c
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 15, 2019
Package DI Number
20386120009289
Quantity per Package
10
Contains DI Package
10386120009282
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |