Duns Number:078613913
Device Description: SCHICK ELITE S1 100 SHEATHS KITUNIVERSAL SHEATHS SIZE 1 (300/PKG)
Catalog Number
-
Brand Name
SCHICK ELITE
Version/Model Number
B1107010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K963664,K963664
Product Code
EFB
Product Code Name
Handpiece, Air-Powered, Dental
Public Device Record Key
c2cd5ce8-3a75-422c-af5a-7d8e12b82ef6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 461 |