Duns Number:536935331
Device Description: FF2 TRANSVERSAL CUTTING GUIDE - The transversal cutting guide is used to guide the saw bla FF2 TRANSVERSAL CUTTING GUIDE - The transversal cutting guide is used to guide the saw blade during bone resection. It has a slot of 0.8mm width and 13mm length in which the saw blade is inserted.
Catalog Number
229012ND
Brand Name
FOREFOOT SOLUTIONS™
Version/Model Number
229012ND
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"
Yes
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
5efd8d68-ab72-436f-830d-9155605cfd9c
Public Version Date
April 03, 2020
Public Version Number
1
DI Record Publish Date
March 26, 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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |