Duns Number:243750762
Device Description: 4 x 50 ml EasySoft liner2 x 10 ml EasySoft liner adhesive(28 mixing tips that are only use 4 x 50 ml EasySoft liner2 x 10 ml EasySoft liner adhesive(28 mixing tips that are only used outside of the mouth and are not medical devices)
Catalog Number
-
Brand Name
EasySoft Liner Laboratory Package
Version/Model Number
0502
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
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
fb26fe35-40fd-47d3-bd09-59c39e9ab717
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 08, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |