Duns Number:879187821
Device Description: Safety Syringe w/ Ndl, 10ML, 25G x 1.5"
Catalog Number
SS10ML25G151
Brand Name
Wealy® RELI®
Version/Model Number
SS10ML25G151
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
K141640,K141640,K141640
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
28588300-9ea0-423a-8d63-97a2a3fa421c
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 15, 2019
Package DI Number
20386120009197
Quantity per Package
8
Contains DI Package
10386120009190
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 |