Duns Number:316153956
Device Description: 5444-0-311 Large Implant (2) / 5444-0-112 Host Bone (1)
Catalog Number
5444-0-310
Brand Name
MEDPOR
Version/Model Number
5444-0-310
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K143173
Product Code
FWP
Product Code Name
PROSTHESIS, CHIN, INTERNAL
Public Device Record Key
c68ed15f-bf77-4c90-af7d-da2f0af4c8b4
Public Version Date
September 13, 2022
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 |