Duns Number:324914910
Device Description: M-PM Disc, PMMA Disc thickness 20mm, diameter 98,5mm, transparent with notch
Catalog Number
1017910
Brand Name
M-PM Disc
Version/Model Number
M-PM Disc, PMMA Disc thickness 20mm, diameter 98,5mm, transparent with notch
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K134015
Product Code
MQC
Product Code Name
Mouthguard, Prescription
Public Device Record Key
295f6446-644e-4449-807d-4b33abf06e81
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 13, 2017
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 12495 |
U | Unclassified | 15 |