Duns Number:079095245
Device Description: NUBOND POSTS, SIZE 3
Catalog Number
EPO1673
Brand Name
NUBOND POST
Version/Model Number
EPO1673
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"
-
For Single-Use
-
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
42d162e6-e227-4cbd-b147-04b80b8c9f55
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
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 | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 128 |