Duns Number:315492330
Device Description: Ti Mini cross slot screw p/10 2x11 grey self-tapp fine thr.
Catalog Number
68.94.73A
Brand Name
Medicon
Version/Model Number
68.94.73A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
9b8e9823-d94a-4224-8849-b0cee8411238
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 30, 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 |