Duns Number:119193803
Device Description: eliminate the damaging effects of disinfectants on costly digital X-ray sensors. Clear pla eliminate the damaging effects of disinfectants on costly digital X-ray sensors. Clear plastic construction aids visibility. 8" long. 500 sheaths per box. Fits sensors up to 1-3/8" wide.
Catalog Number
70-19726
Brand Name
QUIKsheath Barriers Small Digital X-ray Sensor
Version/Model Number
70-19726
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
67bcc37e-e04f-4b76-a0c5-d94366b2d2fb
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009772
Quantity per Package
20
Contains DI Package
00723896009765
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 |