DURAKNOT SW100

GUDID 30705036002882

Endosuture System Suture Assistant

ETHICON ENDO-SURGERY, LLC

Endoscopic 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

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• 30705036040822 - ETHICON: 2025-09-01 ETHICON 3D RELOAD 60MM BLACK
• 20705036040856 - ETHICON: 2025-09-01 ETHICON 3D RELOAD 60MM WHITE
• 20705036043529 - ETHICON: 2025-09-01 ETHICON 4000 STAPLER STRAIGHT 60 STANDARD
• 20705036043536 - ETHICON: 2025-09-01 ETHICON 4000 STAPLER STRAIGHT 60 COMPACT
• 20705036043543 - ETHICON: 2025-09-01 ETHICON 4000 STAPLER STRAIGHT 60 LONG
• 30705036039284 - DUALTO Energy System: 2025-06-30 Ethicon Energy Output Verification Key