Duns Number:008124539
Catalog Number
-
Brand Name
Safety Syringe w/Needle
Version/Model Number
6925
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
K031594,K031594,K031594
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
40f47659-f86c-4533-86bb-aff49f40c14f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
00616784692531
Quantity per Package
8
Contains DI Package
00616784692524
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 694 |
2 | A medical device with a moderate to high risk that requires special controls. | 226 |
3 | A medical device with high risk that requires premarket approval | 2 |