Duns Number:044606982
Device Description: ValuTrus Reusable Linear Stapler Handle, Reusable
Catalog Number
ADLH
Brand Name
ValuTrus
Version/Model Number
ADLH
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 05, 2021
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
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
62aa3de0-6f66-4bfb-a16a-551c454114ee
Public Version Date
August 06, 2021
Public Version Number
3
DI Record Publish Date
August 24, 2015
Package DI Number
30705036013987
Quantity per Package
10
Contains DI Package
20705036013980
Package Discontinue Date
August 05, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |