Duns Number:119193803
Device Description: duce contamination and cleanup time between patients for only pennies per sheath. Unique d duce contamination and cleanup time between patients for only pennies per sheath. Unique design pulls over light handles more easily for an effective barrier. Provides visual assurance of aseptic procedures. Sheaths measure 6-¼" x 3".
Catalog Number
70-19724
Brand Name
QUIKsheath Barriers T-Bar Light Handle
Version/Model Number
70-19724
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
d6426a5e-aa3f-4f97-bd60-5120b1d1af61
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009758
Quantity per Package
20
Contains DI Package
00723896009741
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 |