Duns Number:056296981
Device Description: Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL B Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL Bottle Liquid, 1x130g Bottle Powder, 1x8mL Flow Replenisher
Catalog Number
-
Brand Name
Hydro-Cast®
Version/Model Number
73010
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
EBI
Product Code Name
RESIN, DENTURE, RELINING, REPAIRING, REBASING
Public Device Record Key
c68f38d5-485d-4d70-bed3-8d1be86a492a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
D6870073010FG2
Quantity per Package
12
Contains DI Package
D687730101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |