Echelon Linear Cutter GLC80

GUDID 30705036030885

Echelon Linear Cutter 80mm

ETHICON ENDO-SURGERY, LLC

Open-surgery manual linear cutting stapler, single-use

• Primary Device ID: 30705036030885
• NIH Device Record Key: 6ff99018-b36a-47f5-9728-fc13271ce726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echelon Linear Cutter
• Version Model Number: GLC80
• Catalog Number: GLC80
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036030881 [Primary]
GS1	20705036030888 [Package]; Contains: 10705036030881; Package: BOX [3 Units]; In Commercial Distribution
GS1	30705036030885 [Package]; Contains: 10705036030881; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223760

FDA Product Code

• GDW: Staple, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-23
• Device Publish Date: 2024-04-15

On-Brand Devices [Echelon Linear Cutter]

• 30705036030892: Echelon Linear Cutter 100mm
• 30705036030885: Echelon Linear Cutter 80mm
• 30705036030878: Echelon Linear Cutter 60mm
• 30705036027908: Echelon Linear Cutter Reload 80mm GREEN
• 30705036027892: Echelon Linear Cutter Reload 80mm BLUE
• 40705036027882: Echelon Linear Cutter Reload 60mm GREEN
• 20705036027871: Echelon Linear Cutter Reload 60mm BLUE
• 30705036027861: Echelon Linear Cutter Reload 100mm GREEN
• 20705036027857: Echelon Linear Cutter Reload 100mm BLUE