Duns Number:044606982
Device Description: ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutter , 60mm
Catalog Number
PSEE60A
Brand Name
ECHELON FLEX
Version/Model Number
PSEE60A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
b8b51ba9-2509-4799-bd70-cadd2e55a54e
Public Version Date
October 16, 2019
Public Version Number
3
DI Record Publish Date
August 24, 2015
Package DI Number
20705036014604
Quantity per Package
3
Contains DI Package
10705036014607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |