Duns Number:622185718
Device Description: ParaPost XP Intro Kit - Titanium
Catalog Number
-
Brand Name
ParaPost XP
Version/Model Number
P780T
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
-
Product Code
DZA
Product Code Name
Drill, Dental, Intraoral
Public Device Record Key
9da15b11-d220-40c6-8a6a-880763b29992
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 11, 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 | 553 |
2 | A medical device with a moderate to high risk that requires special controls. | 248 |
U | Unclassified | 10 |