Duns Number:058614483
Device Description: Medium/Thick Circular Reload For use with Signia Circular Adapters
Catalog Number
-
Brand Name
Tri-Staple 2.0
Version/Model Number
SIGCIR28MT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K182475,K182475
Product Code
GDW
Product Code Name
Staple, implantable
Public Device Record Key
3cff7ad2-6e1a-407d-b44b-78926b8306d0
Public Version Date
May 10, 2022
Public Version Number
3
DI Record Publish Date
June 29, 2019
Package DI Number
20884521703725
Quantity per Package
6
Contains DI Package
10884521703728
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |