Duns Number:837845234
Device Description: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Right, 45mm, 2-Hole
Catalog Number
LP4.5-MRT42
Brand Name
PRECICE® Plating System
Version/Model Number
LP4.5-MRT42
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192181
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
92c7051f-1bf9-4e77-91aa-cd7944bc3add
Public Version Date
March 12, 2020
Public Version Number
3
DI Record Publish Date
January 06, 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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2199 |