DURAKNOT SW100

GUDID 30705036002882

Endosuture System Suture Assistant

ETHICON ENDO-SURGERY, LLC

Endoscopic suturing unit, single-use Endoscopic suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use

• Primary Device ID: 30705036002882
• NIH Device Record Key: 7267e7fa-72ad-4acf-8fee-497cb278d219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAKNOT
• Version Model Number: SW100
• Catalog Number: SW100
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036002888 [Unit of Use]
GS1	20705036002885 [Primary]
GS1	30705036002882 [Package]; Contains: 20705036002885; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972679

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

Devices Manufactured by ETHICON ENDO-SURGERY, LLC

• 20705036027857 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 100mm BLUE
• 30705036027861 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 100mm GREEN
• 20705036027871 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 60mm BLUE
• 40705036027882 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 60mm GREEN
• 30705036027892 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 80mm BLUE
• 30705036027908 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter Reload 80mm GREEN
• 30705036030878 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter 60mm
• 30705036030885 - Echelon Linear Cutter: 2024-04-23 Echelon Linear Cutter 80mm