Duns Number:119193803
Device Description: reduce contamination and cleanup time between patients for only pennies per sheath. Unique reduce contamination and cleanup time between patients for only pennies per sheath. Unique pre-punched design pulls over A-W syringes more easily for an effective barrier. Provides visual assurance of aseptic procedures. Measures approximately 8-½" x 2-½".
Catalog Number
70-19720
Brand Name
QUIKsheath Barriers Air-Water Syringe
Version/Model Number
70-19720
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
NRD
Product Code Name
Unit, Operative Dental, Accessories
Public Device Record Key
d2b25587-9318-4564-ad80-2e57e6cc4cc5
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 12, 2018
Package DI Number
00723896009673
Quantity per Package
20
Contains DI Package
00723896009666
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 |