Duns Number:119193803
Device Description: eliminate the damaging effects of cold sterilization on costly digital X-ray sensors. Clos eliminate the damaging effects of cold sterilization on costly digital X-ray sensors. Close-fitting clear plastic construction aids visibility. 8" long. Fits sensors up to 1-5/8" wide
Catalog Number
70-19727
Brand Name
QUIKsheath Barriers Large Digital X-Ray Sensor
Version/Model Number
70-19727
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
16533a88-668a-4738-8cb6-b3370641115e
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009796
Quantity per Package
20
Contains DI Package
00723896009789
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 |