GYNECARE INTERCEED 4350XL

GUDID 20705031147840

Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose

ETHICON, LLC

Surgical anti-adhesion dressing, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

• Primary Device ID: 20705031147840
• NIH Device Record Key: 773a32bb-4234-4dd0-b91c-09ce92cffcfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYNECARE INTERCEED
• Version Model Number: 4350XL
• Catalog Number: 4350XL
• Company DUNS: 829465157
• Company Name: ETHICON, 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)384-4266
• 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
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031147843 [Primary]
GS1	20705031147840 [Package]; Contains: 10705031147843; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880047

FDA Product Code

• MCN: BARRIER, ABSORABLE, ADHESION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-30
• Device Publish Date: 2014-09-20

On-Brand Devices [GYNECARE INTERCEED]

• 20705031005393: Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose
• 20705031147840: Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose