Duns Number:837845234
Device Description: PRECICE Plate 4.5mm Posteromedial Proximal Tibia Plate, Left, 35mm, 0-Hole
Catalog Number
LP4.5-MLT30
Brand Name
PRECICE® Plating System
Version/Model Number
LP4.5-MLT30
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)
Yes
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
d729905a-3b50-4299-b9a6-5ffc49d52e13
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 |