Duns Number:109903521
Device Description: EVOS 2.7/3.5MM MEDIAL DISTAL HUMERUS TEMPLATE 7H L 124M EVOS 2.7/3.5MM MEDIAL DISTAL HUMERUS TEMPLATE 7H L 124MM
Catalog Number
76115507
Brand Name
EVOS
Version/Model Number
76115507
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
HWT
Product Code Name
TEMPLATE
Public Device Record Key
b0068ac6-b364-4475-bd64-b4f5c407b87e
Public Version Date
December 30, 2020
Public Version Number
1
DI Record Publish Date
December 22, 2020
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 |