Duns Number:001006089
Device Description: EMBRACE OPAQUER Dark Yellow 1.2mL/2.1 gm syringe
Catalog Number
-
Brand Name
EMBRACE ESTHETIC OPAQUERS
Version/Model Number
EMO5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2020
Issuing Agency
In HIBCC
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)
Yes
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
K031877
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
58d8dafb-d9b5-4c4e-8f68-bfaa0eda9182
Public Version Date
January 01, 2020
Public Version Number
2
DI Record Publish Date
November 22, 2019
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 | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |