Duns Number:119193803
Device Description: an infection control shield built right in that reduces splash-back and cross contaminatio an infection control shield built right in that reduces splash-back and cross contamination! The non-removable shields adjust forward or backward to accommodate varying working positions and water pressures.Does not interfere with working field or visibility Aids in cheek retraction Besides their protection value, No-Splash tips are precision-molded to deliver powerful dry air, water and mist functions without leaking. Fit all standard 3-way A-W syringes using quick change-style metal tips-no adapter required. 150 tips per dispenser box in three assorted colors.
Catalog Number
70-42611
Brand Name
No-Splash Air-Water Syringe Tips
Version/Model Number
70-42611
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
-
Product Code
ECB
Product Code Name
Unit, Syringe, Air And/Or Water
Public Device Record Key
ebee35fa-618d-4bbb-9339-5153d3114be8
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009994
Quantity per Package
45
Contains DI Package
00723896009987
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 |