Duns Number:942377524
Device Description: The Movement Great Toe metatarsal sizer allows for clear visualization of the implant size The Movement Great Toe metatarsal sizer allows for clear visualization of the implant size.
Catalog Number
-
Brand Name
Movement®
Version/Model Number
MIS89000
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
K092047
Product Code
KWD
Product Code Name
PROSTHESIS, TOE, HEMI-, PHALANGEAL
Public Device Record Key
ba814b65-4903-4de0-8637-b9a3fe2ec711
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
August 15, 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 |