Duns Number:784664955
Device Description: Chin Implant
Catalog Number
VLC-L
Brand Name
Vertical Lengthening Chin
Version/Model Number
Size: Large
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
K904657,K911516
Product Code
FWP
Product Code Name
Prosthesis, Chin, Internal
Public Device Record Key
58b3e433-2eb5-4691-b80b-591eb0fe5dbb
Public Version Date
November 15, 2019
Public Version Number
5
DI Record Publish Date
September 24, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 58 |
2 | A medical device with a moderate to high risk that requires special controls. | 1251 |