Duns Number:315731711
Device Description: 3M™ ESPE™ Ketac™ Bond Double Pack, 2 Powder 10 g each, Shade Yellow, 1 Liquid 12 mL, 37390
Catalog Number
37390
Brand Name
Ketac™ Bond
Version/Model Number
37390
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
EBD
Product Code Name
COATING, FILLING MATERIAL, RESIN
Public Device Record Key
dd05ce69-8921-4f78-895b-380e29e52087
Public Version Date
December 10, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |