Duns Number:043957315
Device Description: Regenerative Collagen Dental Bone Graft Composite
Catalog Number
-
Brand Name
Karl Schumacher Composite Putty
Version/Model Number
RCBP0100
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
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
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
acc77152-cfe7-4245-9754-8965d84ef89e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 26, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |