PROLENE PHSL, PHSL1, PHSL6

GUDID 20705031048956

Polypropylene Nonabsorbable Synthetic Surgical Mesh

ETHICON INC.

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 20705031048956
• NIH Device Record Key: 2d56fbdf-360c-4355-b9d6-dbf13a6a24f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROLENE
• Version Model Number: PHSL
• Catalog Number: PHSL, PHSL1, PHSL6
• Company DUNS: 002144145
• Company Name: ETHICON INC.
• 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)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031048966 [Primary]
GS1	20705031048956 [Package]; Contains: 10705031048966; Package: BOX [3 Units]; In Commercial Distribution
GS1	20705031048963 [Package]; Contains: 10705031048966; Package: BOX [1 Units]; In Commercial Distribution
GS1	20705031048970 [Package]; Contains: 10705031048966; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180829

FDA Product Code

• FTL: Mesh, surgical, polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2021-09-02
• Device Publish Date: 2015-09-24

On-Brand Devices [PROLENE]

• 10705031048935: Prolene (Polypropylene) Hernia System Nonabsorbable Synthetic Surgical Mesh
• 20705031005133: Polyproplylene Nonabsorbable Synthetic Surgical Mesh
• 20705031048987: Polypropylene Nonabsorbable Synthetic Surgical Mesh
• 20705031048956: Polypropylene Nonabsorbable Synthetic Surgical Mesh
• 20705031047515: Polyproplylene Nonabsorbable Synthetic Surgical Mesh
• 20705031047492: Polyproplylene Nonabsorbable Synthetic Surgical Mesh
• 20705031005157: Polyproplylene Nonabsorbable Synthetic Surgical Mesh