ECHELON ECH45C

GUDID 30705036034999

ECHELON 3000 45MM COMPACT

ETHICON ENDO-SURGERY, LLC

Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use Endoscopic motorized cutting stapler, single-use

• Primary Device ID: 30705036034999
• NIH Device Record Key: 292ebb00-8aed-4515-be36-f8f1c0b46679
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHELON
• Version Model Number: ECH45C
• Catalog Number: ECH45C
• Company DUNS: 044606982
• Company Name: ETHICON ENDO-SURGERY, LLC
• Device Count: 1
• 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)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4267
• Email: customersupport@eesus.jnj.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036034995 [Primary]
GS1	20705036034992 [Package]; Contains: 10705036034995; Package: BOX [3 Units]; In Commercial Distribution
GS1	30705036034999 [Package]; Contains: 10705036034995; Package: CASE [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213633

FDA Product Code

• GAG: Stapler, surgical

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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [ECHELON]

• 20705036027512: ECHELON CONTOUR W/ BLUE RELOAD
• 20705036027505: ECHELON CONTOUR W/ GREEN RELOAD
• 30705036027472: ECHELON CONTOUR GST RELOAD GREEN
• 20705036027468: ECHELON CONTOUR GST RELOAD BLUE
• 20705036035012: ECHELON 3000 60MM STANDARD
• 20705036035005: ECHELON 3000 45 STANDARD
• 30705036034999: ECHELON 3000 45MM COMPACT
• 20705036034985: ECHELON 3000 60MM LONG
• 30705036034975: ECHELON 3000 60MM COMPACT
• 20705036034961: ECHELON 3000 45MM LONG