ECHELON ENDOPATH GST45B

GUDID 30705036014885

The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The 45 mm instruments have a staple line thatis approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portionof the shaft to facilitate lateral access of the operative site.The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments’ lock-out feature is designed to prevent a used reload from being refired.

ETHICON ENDO-SURGERY, LLC

Surgical staple loading unit, non-cutting
Primary Device ID30705036014885
NIH Device Record Key34f31c66-0f8a-4263-82d7-e02ba33315b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameECHELON ENDOPATH
Version Model NumberGST45B
Catalog NumberGST45B
Company DUNS044606982
Company NameETHICON ENDO-SURGERY, LLC
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Customer Support Contacts

Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110705036014881 [Unit of Use]
GS120705036014888 [Primary]
GS130705036014885 [Package]
Contains: 20705036014888
Package: CASE [420 Units]
In Commercial Distribution
GS140705036014882 [Package]
Contains: 10705036014881
Package: CASE [192 Units]
In Commercial Distribution

FDA Product Code

GDWSTAPLE, IMPLANTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2017-02-22

On-Brand Devices [ECHELON ENDOPATH]

30705036014922The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
30705036014915The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
30705036014908The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
30705036014892The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
30705036014885The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of endoscopic linear cutters and r
30705036014724Endopath Echelon Endoscopic Linear Cutter Reloads, Black, 60mm
30705036014717Endopath Echelon Endoscopic Linear Cutter Reloads, Green, 60mm
30705036014700Endopath Echelon Endoscopic Linear Cutter Reloads, Blue, 60mm
30705036014694Endopath Echelon Endoscopic Linear Cutter Reloads, Gold, 60mm
30705036014687Endopath Echelon Endoscopic Linear Cutter Reloads, White, 60mm
30705036014595ENDOPATH ECHELON Vascular Reloads, White, 35mm
30705036014366Endoscopic Linear Cutter Reloads Black 4.4mm, 6 rows
30705036013796Endoscopic Linear Cutter Reloads Gray 2.0mm, 6 rows
30705036002448Echelon Flex 60 Enotpath Stapler Long Articulating Endoscopic Linear Cutter
30705036002431Echelon 60 Endopath Stapler Long Endoscopic Linear Cutter--Staight, No reload
30705036001793Endoscopic Linear Cutter Reloads White 2.5 mm, 6 rows
30705036001717Echelon 45 Endopath Stapler, Long Endoscopic Linear Cutter-Straight (No cartridge), 440 mm
30705036001694Echelon 60 Endopath Stapler, Endoscopic Linear Cutter-Straight (No cartridge)
30705036001687Echelon Flex45 Endopath Stapler, Long Articulating Endoscopic Linear Cutter (No cartridge)
30705036001670Echelon Flex45 Endopath Stapler, Articulating Endoscopic Linear Cutter (No cartridge)
30705036001663ECHELON 45 Endoscopic Linear Cutter Straight 340 mm No cartridge

Trademark Results [ECHELON ENDOPATH]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ECHELON ENDOPATH
ECHELON ENDOPATH
86518166 5649458 Live/Registered
Johnson & Johnson
2015-01-29

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