Duns Number:316153956
Device Description: Petite Nasal Dorsum
Catalog Number
84003
Brand Name
MEDPOR
Version/Model Number
84003
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
K922489
Product Code
FWP
Product Code Name
PROSTHESIS, CHIN, INTERNAL
Public Device Record Key
5ac79434-4987-4167-9dc7-d047e602fc57
Public Version Date
October 12, 2020
Public Version Number
4
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 | 777 |
2 | A medical device with a moderate to high risk that requires special controls. | 2520 |