Dextera MicroCutter 5/80 Stapler FG-025302

GUDID 11814900003025

Endoscopic Surgical Stapler

AESDEX, LLC

Endoscopic manual linear cutting stapler, single-use
Primary Device ID11814900003025
NIH Device Record Key0c8e4412-90ad-44bf-96a4-738c807daa32
Commercial Distribution StatusIn Commercial Distribution
Brand NameDextera MicroCutter 5/80 Stapler
Version Model NumberFG-025302
Catalog NumberFG-025302
Company DUNS081132841
Company NameAESDEX, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS111814900003025 [Primary]

FDA Product Code

GAGStapler, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-19
Device Publish Date2016-07-25

Devices Manufactured by AESDEX, LLC

11814900003100 - MicroCutter 30 White Reload2019-05-07 MicroCutter 30 White Reload is compatible with the MicroCutter 5/80 Stapler
11814900003117 - MicroCutter 30 Curved Tip White Reload2019-05-07 MicroCutter 30 Curved Tip White Reload is compatible with the MicroCutter 5/80 Stapler
11814900003209 - MicroCutter 30 Blue Reload2019-05-07 MicroCutter 30 Blue Reload is compatible with the MicroCutter 5/80 Stapler
11814900003216 - MicroCutter 30 Curved Tip Blue Reload2019-05-07 MicroCutter 30 Curved Tip Blue Reload is compatible with the MicroCutter 5/80 Stapler
11814900000031 - Cardica Vein/Aorta Gauge2019-03-11 The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diamet
11814900000017 - Cardica PAS-Port Proximal Anastomosis System2018-12-19 PAS-Port Proximal Anastomosis System
11814900001007 - Cardica C-Port xA Plus Anastomosis System2018-12-19 C-Port xA Plus Anastomosis System
11814900001502 - Cardica C-Port Flex-A Plus Distal Anastomosis Syst2018-12-19 C-Port FLEX-A Plus Distal Anastomosis System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.