Echelon Linear Cutter GLCR100B

GUDID 20705036027857

Echelon Linear Cutter Reload 100mm BLUE

ETHICON ENDO-SURGERY, LLC

Surgical staple loading unit, non-cutting

• Primary Device ID: 20705036027857
• NIH Device Record Key: 3e637620-41a6-480b-bdde-e6380901b970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echelon Linear Cutter
• Version Model Number: GLCR100B
• Catalog Number: GLCR100B
• 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	10705036027850 [Primary]
GS1	20705036027857 [Package]; Contains: 10705036027850; Package: BOX [12 Units]; In Commercial Distribution
GS1	30705036027854 [Package]; Contains: 10705036027850; Package: CASE [96 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]

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• 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