Duns Number:080068420
Device Description: MTPJ Plate Small Left, 5 deg Dorsiflexion/5 deg Abduction, EPS
Catalog Number
-
Brand Name
FirstFUSE 1st MTP Joint Plating System
Version/Model Number
12320055
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
142eae8d-6257-4106-bf30-50d0220428e5
Public Version Date
November 02, 2020
Public Version Number
1
DI Record Publish Date
October 23, 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 | 65 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 626 |