Duns Number:109903521
Device Description: EVOS DISTAL RADIUS VOLAR PLATE 3 HOLE LEFT STANDARD 48M EVOS DISTAL RADIUS VOLAR PLATE 3 HOLE LEFT STANDARD 48MM
Catalog Number
72468103N
Brand Name
EVOS
Version/Model Number
72468103N
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
K181533
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
ed630dad-cdb8-425d-b05a-b58fa89a9274
Public Version Date
November 03, 2020
Public Version Number
2
DI Record Publish Date
September 04, 2018
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |