ProLayer Xenograft

GUDID 00855638007026

Acellular Dermal Matrix

STELLEN MEDICAL, LLC

Multi-purpose surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

• Primary Device ID: 00855638007026
• NIH Device Record Key: c9df1049-17a0-44b7-9751-36463d90fc99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLayer Xenograft
• Version Model Number: 3102-2147
• Company DUNS: 801160037
• Company Name: STELLEN MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com
• Phone: 800-943-4520
• Email: customerservice@stellenmedical.com

Device Dimensions

• Length: 7 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter
• Width: 4 Centimeter
• Length: 7 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855638007026 [Primary]

FDA Product Code

• FTM: Mesh, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-06

On-Brand Devices [ProLayer Xenograft]

• 00855638007033: Acellular dermal matrix
• 00855638007026: Acellular Dermal Matrix
• 00855638007019: Acellular Dermal Matrix
• 00855638007002: Acellular Dermal Matrix