Duns Number:942377524
Device Description: Integra® First Choice® DRUJ SystemMUH Stem ImpactorThe Modular Ulnar Head stem impactor im Integra® First Choice® DRUJ SystemMUH Stem ImpactorThe Modular Ulnar Head stem impactor impacts the stem into selected head placed in the back table assembly.
Catalog Number
IMP-600-00
Brand Name
First Choice® DRUJ System
Version/Model Number
IMP60000
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
HWA
Product Code Name
IMPACTOR
Public Device Record Key
d52324e1-eb6d-42e6-9867-ab7311d92e1b
Public Version Date
December 11, 2020
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 |