Duns Number:626959824
Device Description: Large Round Chin
Catalog Number
CCR-9064
Brand Name
Biopor®
Version/Model Number
CCR-9064
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKY
Product Code Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Public Device Record Key
65d831e8-878a-4cb2-9b68-dc8b7df0d8a4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 20, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 64 |