Duns Number:119193803
Device Description: Clear air/water syringe tips
Catalog Number
7158210
Brand Name
Clear Disposable A-W Syringe Tips
Version/Model Number
7158210
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
-
Product Code
ECB
Product Code Name
Unit, Syringe, Air And/Or Water
Public Device Record Key
528ad532-a888-41dd-b1d0-98de9ae4d6eb
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
July 23, 2021
Package DI Number
00723896019627
Quantity per Package
48
Contains DI Package
00723896019610
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 | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |