Duns Number:942377524
Device Description: Integra®Total Foot SystemThe k-wire distraction/compression forceps are used to hold k-wir Integra®Total Foot SystemThe k-wire distraction/compression forceps are used to hold k-wire in the Integra Total Foot System.
Catalog Number
KDF-TFS-00
Brand Name
Integra®
Version/Model Number
KDFTFS00
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
HTD
Product Code Name
FORCEPS
Public Device Record Key
25a2b380-f851-41e5-a70a-f12183fbeed9
Public Version Date
August 11, 2020
Public Version Number
5
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 |