Duns Number:315492330
Device Description: Ti Midface L plate 90° 2x2 holes rt long
Catalog Number
68.81.60
Brand Name
Medicon
Version/Model Number
68.81.60
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
-
Product Code
JEY
Product Code Name
PLATE, BONE
Public Device Record Key
ffe600d0-ce13-4e51-9a05-919784951c86
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
May 07, 2020
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 | 7911 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1064 |