Duns Number:020417380
Device Description: Safco strip-off crown #B1 lrg 9mm 5b
Catalog Number
1026514
Brand Name
Safco polycarbonate crowns
Version/Model Number
1026514
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
-
Product Code
ELZ
Product Code Name
CROWN, PREFORMED
Public Device Record Key
00b4a482-eeab-402f-a5c8-f87495a48361
Public Version Date
August 11, 2021
Public Version Number
2
DI Record Publish Date
May 14, 2021
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 | 600 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |