Duns Number:942377524
Device Description: Integra® External Fixation SystemThe Maintenance Kit consists of a 10mm and 13mm box wrenc Integra® External Fixation SystemThe Maintenance Kit consists of a 10mm and 13mm box wrench, a universal bolt tubular wrench, a pivoting socket wrench, and a k-wire guide. These instruments are used with the Integra External Fixation System.
Catalog Number
1222MAINKIT
Brand Name
Integra®
Version/Model Number
1222MAINKIT
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
HXC
Product Code Name
WRENCH
Public Device Record Key
8626591f-a777-4ca8-82a6-361122ded8db
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 05, 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 |