Duns Number:015108087
Device Description: Sterling Crown Master Remover. Bend-resistant, heat-resistant, autoclavable, fiberglass pl Sterling Crown Master Remover. Bend-resistant, heat-resistant, autoclavable, fiberglass plier for positioning of inlays. Holds bridges and crowns while separating sprilles with a disc.
Catalog Number
-
Brand Name
STERLING
Version/Model Number
3087-312
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EIS
Product Code Name
Remover, Crown
Public Device Record Key
1ecd24a9-3343-4e26-9d3c-ef6b3fc4e3f6
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 21, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |