ECHELON; ENDOPATH ECR45M

GUDID 30705036001755

Endoscopic Linear Cutter Reloads Gray 2.0 mm

ETHICON ENDO-SURGERY, LLC

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• Primary Device ID: 30705036001755
• NIH Device Record Key: ca974b20-b47f-403b-aaa5-82da2099e283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHELON; ENDOPATH
• Version Model Number: ECR45M
• Catalog Number: ECR45M
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 12
• 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
• 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	10705036001751 [Unit of Use]
GS1	20705036001758 [Primary]
GS1	30705036001755 [Package]; Contains: 20705036001758; Package: CASE [420 Units]; In Commercial Distribution
GS1	40705036001752 [Package]; Contains: 10705036001751; Package: CASE [192 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080839

FDA Product Code

• GDW: STAPLE, IMPLANTABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2015-08-24

On-Brand Devices [ECHELON; ENDOPATH]

• 30705036011846: Endoscopic Linear Cutter Reloads Gold 3.8 mm
• 30705036001786: Endoscopic Linear Cutter Reloads Green 4.1 mm, 6 rows
• 30705036001779: Endoscopic Linear Cutter Reloads Blue 3.5mm
• 30705036001762: Endoscopic Linear Cutter Reloads White 2.5 mm
• 30705036001755: Endoscopic Linear Cutter Reloads Gray 2.0 mm
• 30705036001748: Endoscopic Linear Cutter Reloads Green 4.1 mm
• 30705036001731: Endoscopic Linear Cutter Reloads Gold 3.8 mm
• 30705036001724: Endoscopic Linear Cutter Reloads Blue 3.5mm