Duns Number:015108087
Device Description: Emulate Alginate Regular Set Case of 8 Pouches
Catalog Number
-
Brand Name
EMULATE
Version/Model Number
3278-768
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
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
adde2c80-8290-48a1-a95a-a7338ec65dcd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 02, 2017
Package DI Number
D74432787681
Quantity per Package
8
Contains DI Package
D74432787680
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1364 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 377 |
| U | Unclassified | 15 |