Duns Number:257382580
Device Description: The OPSoft mouthguard is intended for protection during hair removal, cutaneous treatment, The OPSoft mouthguard is intended for protection during hair removal, cutaneous treatment, and perioral procedures with laser, IPL or RF.
Catalog Number
-
Brand Name
OPSoft® Mouthguards for laser (1 unit)
Version/Model Number
60-104S
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
-
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
BRW
Product Code Name
Protector, Dental
Public Device Record Key
8347d8e4-f187-4b4b-a371-68a4d8c95bd6
Public Version Date
December 03, 2019
Public Version Number
1
DI Record Publish Date
November 25, 2019
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 | 192 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |