Duns Number:480054895
Device Description: 2.8 TriLock Clavicle Plate Superior Midshaft, 8 Hole, Right, High Bend
Catalog Number
A-4851.28
Brand Name
APTUS
Version/Model Number
A-4851.28
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
K192984
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
cdb4f1e4-ec2d-411e-90f6-a0994a022853
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 22, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1521 |