Duns Number:056624901
Device Description: Package of 1 disc 98mmX16mm with shoulder
Catalog Number
PCSD16
Brand Name
The Original Clearsplint Disc
Version/Model Number
PCSD16
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
K111828
Product Code
MQC
Product Code Name
Mouthguard, Prescription
Public Device Record Key
7980d787-377f-44ee-b9b7-6b1d358e5d7a
Public Version Date
July 26, 2021
Public Version Number
1
DI Record Publish Date
July 16, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 33 |
U | Unclassified | 10 |