Duns Number:058759296
Device Description: Non-sterile, silicone, chin implant.
Catalog Number
VCH - 5 F
Brand Name
Chin Implant
Version/Model Number
VCH - 5 F
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
K973575
Product Code
FWP
Product Code Name
Prosthesis, Chin, Internal
Public Device Record Key
24fef7ce-c337-4408-b4cb-eee6cdaef111
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 28, 2015
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. | 592 |