Duns Number:058614483
Device Description: Irrigation Channel; For use with Circular Reloads
Catalog Number
-
Brand Name
Tri-Staple 2.0
Version/Model Number
SIGCIRIC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2022
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
K182475,K182475
Product Code
GDW
Product Code Name
Staple, implantable
Public Device Record Key
0feadac4-6997-46de-8903-b6db0ca102d0
Public Version Date
October 17, 2022
Public Version Number
3
DI Record Publish Date
June 29, 2019
Package DI Number
20884521703718
Quantity per Package
6
Contains DI Package
10884521703711
Package Discontinue Date
October 12, 2022
Package Status
Not 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 |