Duns Number:058614483
Device Description: Circular Stapler with Tri-Staple Technology
Catalog Number
TRIEEAXL31MT
Brand Name
EEA
Version/Model Number
TRIEEAXL31MT
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
K172361,K172361
Product Code
GDW
Product Code Name
Staple, implantable
Public Device Record Key
610b8b12-d9ee-4ae9-9e8e-6bf9b86160b4
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 19, 2020
Package DI Number
20884521593142
Quantity per Package
3
Contains DI Package
10884521593145
Package Discontinue Date
-
Package Status
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 | 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 |