Duns Number:942377524
Device Description: Integra® Total Foot SystemThe Bending Pliers are used to bend pre-countored plates to matc Integra® Total Foot SystemThe Bending Pliers are used to bend pre-countored plates to match specific patient anatomy.
Catalog Number
503004124
Brand Name
Integra®
Version/Model Number
503 004124
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
HTC
Product Code Name
PLIERS, SURGICAL
Public Device Record Key
2283444c-69f6-4efe-8216-17a39311b20b
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 |