ECHLEON ECH60R

GUDID 20705036023293

ECHELON 60MM REINFORCEMENT

ETHICON ENDO-SURGERY, LLC

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Multi-purpose surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 20705036023293
• NIH Device Record Key: 5dc2f39e-84ff-4e3b-861d-431f1490a44a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECHLEON
• Version Model Number: ECH60R
• Catalog Number: ECH60R
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705036023296 [Primary]
GS1	20705036023293 [Package]; Contains: 10705036023296; Package: BOX [6 Units]; In Commercial Distribution
GS1	30705036023290 [Package]; Contains: 10705036023296; Package: CASE [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190937

FDA Product Code

• OXC: Mesh, surgical, absorbable, staple line reinforcement

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: 2021-11-25
• Device Publish Date: 2021-11-17

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