Duns Number:137217043
Catalog Number
106-1502
Brand Name
SCOTT'S SELECT ALLOY 50/jar 2 SPILL
Version/Model Number
106-1502
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140125,K140125
Product Code
EJJ
Product Code Name
Alloy, Amalgam
Public Device Record Key
5973dd0c-8c4a-4061-ad58-8cf474ec27a2
Public Version Date
August 26, 2020
Public Version Number
4
DI Record Publish Date
May 25, 2017
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 | 1050 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |