Duns Number:796416191
Device Description: 4.5mm Contour Locking Compression Femur Plate Right, Size 12
Catalog Number
00-1065-4012
Brand Name
Pediloc Locking Plate System
Version/Model Number
00-1065-4012
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
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
49d1e260-1a95-408b-b55d-361f09ddade0
Public Version Date
March 23, 2020
Public Version Number
1
DI Record Publish Date
March 13, 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 | 1662 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7273 |