Duns Number:005473608
Device Description: EPITEX® Refill Packages Contains: 1 Reel Coarse (Blue)
Catalog Number
473011
Brand Name
EPITEX®
Version/Model Number
473011
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
5a5222fb-7e26-4c66-b709-64bbced09a90
Public Version Date
April 25, 2018
Public Version Number
3
DI Record Publish Date
February 10, 2017
Package DI Number
D6584730112
Quantity per Package
5
Contains DI Package
D6584730111
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 |