Duns Number:005473608
Device Description: EPITEX® Starter package Contains: 1 Reel each of Coarse, Medium, Fine & Extra Fine strips EPITEX® Starter package Contains: 1 Reel each of Coarse, Medium, Fine & Extra Fine strips 5mm wide, 1 Reel of Translucent matrix strip, work station
Catalog Number
473005
Brand Name
EPITEX®
Version/Model Number
473005
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
EHM
Product Code Name
STRIP, POLISHING AGENT
Public Device Record Key
f946b7db-26cb-4afb-be4d-4b00c83bd6bb
Public Version Date
April 25, 2018
Public Version Number
3
DI Record Publish Date
February 10, 2017
Package DI Number
D6584730052
Quantity per Package
5
Contains DI Package
D6584730051
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |