Duns Number:138041277
Device Description: Lapidus Hook Plate Drill Guide, Lt, 1.8mm
Catalog Number
GDLAPHL-1.8
Brand Name
Tools - FPS
Version/Model Number
GDLAPHL-1.8
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
d410dcd5-b520-4d94-8fc8-bac40be1d6fb
Public Version Date
April 06, 2020
Public Version Number
2
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 |