Duns Number:942377524
Device Description: Movement® Great Toe SystemProximal Phalanx BroachThe Movement Great Toe Proximal Phalanx B Movement® Great Toe SystemProximal Phalanx BroachThe Movement Great Toe Proximal Phalanx Broach is used to prepare a cavity that provides a press fit for the implant.
Catalog Number
PPB89000
Brand Name
Movement®
Version/Model Number
PPB-890-00
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
HTQ
Product Code Name
BROACH
Public Device Record Key
cd7a703d-7e0e-4d8b-aecc-55a164707a8a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 30, 2017
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 |