Duns Number:063519193
Device Description: Curing Light Sleeves Fits Coltene - Whaledent SPEC3 Box of 100
Catalog Number
21109
Brand Name
TIDISHIELD
Version/Model Number
21109
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"
Yes
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
PEM
Product Code Name
Dental Barriers And Sleeves
Public Device Record Key
30620fe0-6592-4fc0-b4eb-81e1d16db582
Public Version Date
May 21, 2021
Public Version Number
7
DI Record Publish Date
October 04, 2016
Package DI Number
10618125134516
Quantity per Package
5
Contains DI Package
00618125134519
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |