Duns Number:044606982
Device Description: Circular Stapler Reload, 25.5mm, Disposable
Catalog Number
ADC255R
Brand Name
ValuTrus
Version/Model Number
ADC255R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 07, 2019
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
a238e3be-0379-403e-9792-b64cafe3cf5b
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
August 24, 2015
Package DI Number
30705036014649
Quantity per Package
72
Contains DI Package
20705036014642
Package Discontinue Date
November 07, 2019
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 |