Duns Number:013369913
Device Description: UniCore Post Size #2 25pk
Catalog Number
4097
Brand Name
UniCore
Version/Model Number
4097
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
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
734f9a90-c030-413b-88be-7a7b4a0a8fa6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 07, 2018
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 | 450 |
2 | A medical device with a moderate to high risk that requires special controls. | 631 |
U | Unclassified | 18 |