Duns Number:009900424
Device Description: SHARP™ Medium Body Premium Hydrophilic VPS Impression Material
Catalog Number
S511
Brand Name
SHARP™
Version/Model Number
S511
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2019
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
Yes
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
6ce20c37-b51b-48ea-93d3-2cce023b1d78
Public Version Date
April 01, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M595S5111
Quantity per Package
2
Contains DI Package
M595S5110
Package Discontinue Date
January 01, 2019
Package Status
Not 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |