Duns Number:315492330
Device Description: Ti Mini plate 2x24 hole 0.6mm
Catalog Number
68.81.68
Brand Name
Medicon
Version/Model Number
68.81.68
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)
-
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
0c6f9e56-5460-4291-9a3e-1e7e988cf9a8
Public Version Date
October 29, 2021
Public Version Number
1
DI Record Publish Date
October 21, 2021
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 |