Duns Number:119193803
Device Description: cut contamination and clean-up time between patients for only pennies per sheath. Unique p cut contamination and clean-up time between patients for only pennies per sheath. Unique pre-punched design pulls over instruments and scalers more easily for an effective barrier. Ideal for covering intraoral camera scopes, slimmer handpieces, ultrasonic scalers and pens. Provides visual assurance of aseptic procedures. 9" x 1-½"
Catalog Number
7019723
Brand Name
QUIKsheath Barriers Scaler/Instrument
Version/Model Number
7019723
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
9b46ea76-8c0b-4ffd-9b3c-59163daed08a
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009734
Quantity per Package
20
Contains DI Package
00723896009727
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 |