Duns Number:044606982
Device Description: ETS-Flex45 Endoscopic Articulating Linear Cutter
Catalog Number
6TB45
Brand Name
ENDOPATH
Version/Model Number
6TB45
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 22, 2017
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
bb845f34-3ac5-48ea-b215-c8e6be869f7b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 24, 2015
Package DI Number
30705036000871
Quantity per Package
9
Contains DI Package
20705036000874
Package Discontinue Date
February 22, 2017
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 |