Duns Number:054028295
Device Description: Dental Root Canal Post
Catalog Number
C810001
Brand Name
Two Striper
Version/Model Number
SNOWPOST BASIC KIT- 50 ASSTD W/DRILLS
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
-
Product Code
ELR
Product Code Name
POST, ROOT CANAL
Public Device Record Key
90e9d14b-d6ed-44f8-86ec-b518d54f7ac4
Public Version Date
June 02, 2021
Public Version Number
1
DI Record Publish Date
May 25, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2300 |