Duns Number:942377524
Device Description: LMP System Implant Trial Sizer 40The trial sizers are used to select the correct size impl LMP System Implant Trial Sizer 40The trial sizers are used to select the correct size implant, and to be certain that all soft contractures have been released. It is important to load the foot with thetrial sizer in place to be certain there is no jamming of the implant.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
LMP-405T
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
-
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
HWT
Product Code Name
TEMPLATE
Public Device Record Key
e79a5fe5-5d0c-49d0-9dc5-6f92bd505415
Public Version Date
March 22, 2019
Public Version Number
5
DI Record Publish Date
July 25, 2016
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |