Duns Number:942377524
Device Description: Integra® BioMotion® Cannulated Hemi SystemThe smooth guide wire is used as a guide for pla Integra® BioMotion® Cannulated Hemi SystemThe smooth guide wire is used as a guide for placement or insertion of a device.
Catalog Number
HW 1100
Brand Name
BioMotion® Cannulated 1st MPJ Hemi System
Version/Model Number
HW 1100
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
Yes
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
HXI
Product Code Name
PASSER, WIRE, ORTHOPEDIC
Public Device Record Key
6924f890-d610-40c2-bd64-c0b6acb60e6a
Public Version Date
October 05, 2018
Public Version Number
3
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 |