ETHIBOND; DURAKNOT SW122

GUDID 30705036002929

Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester Suture

ETHICON ENDO-SURGERY, LLC

Endoscopic suturing unit, single-use
Primary Device ID30705036002929
NIH Device Record Key5fba6e56-396c-4ccb-ae15-cba0a83f8ff0
Commercial Distribution StatusIn Commercial Distribution
Brand NameETHIBOND; DURAKNOT
Version Model NumberSW122
Catalog NumberSW122
Company DUNS044606982
Company NameETHICON ENDO-SURGERY, LLC
Device Count10
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705036002925 [Unit of Use]
GS120705036002922 [Primary]
GS130705036002929 [Package]
Contains: 20705036002922
Package: CASE [350 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

On-Brand Devices [ETHIBOND; DURAKNOT]

30705036002929Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester
30705036002912Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester
30705036002905Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester
30705036002899Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester

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