Duns Number:486717338
Device Description: Super hydrophilic correction impression material based on addition curing vinyl silicones Super hydrophilic correction impression material based on addition curing vinyl silicones - Heavy body, regular set
Catalog Number
SEL-SIL-SHRS-GR50
Brand Name
Select Sil Heavy Viscosity
Version/Model Number
SEL-SIL-SHRS-GR50
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
ELW
Product Code Name
Material, Impression
Public Device Record Key
e319eb59-0eb0-4b54-951c-49efdbf6de3d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 21, 2017
Package DI Number
17540208000247
Quantity per Package
2
Contains DI Package
07540208000240
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |