Duns Number:121411859
Device Description: ENDODONTIC SPRAY PULP VITALITY REFRIGERANT
Catalog Number
-
Brand Name
ENDODONTIC SPRAY
Version/Model Number
#ENSP
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EAT
Product Code Name
Tester, Pulp
Public Device Record Key
9b78cf59-58e2-42ea-b053-65cf8bec23c1
Public Version Date
April 02, 2018
Public Version Number
1
DI Record Publish Date
February 28, 2018
Package DI Number
10860177000626
Quantity per Package
12
Contains DI Package
00860177000629
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |