Duns Number:138041277
Device Description: Lapidus Hook Plt, Lt, 5-Hole, Template
Catalog Number
LAPHL-5 T
Brand Name
Tools - FPS
Version/Model Number
LAPHL-5 T
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)
-
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
0e886066-69a8-42d5-88e8-1fd0a5cbf8cc
Public Version Date
January 28, 2020
Public Version Number
1
DI Record Publish Date
January 20, 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 | 555 |
2 | A medical device with a moderate to high risk that requires special controls. | 1934 |