OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex) F10254-0610G

GUDID 09421904065222

OviTex™ Core Reinforced Tissue Matrix with Resorbable Polymer (OviTex) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and polyglycolic acid (PGA). OviTex will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. OviTex is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient’s requirements.

AROA BIOSURGERY LIMITED

Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable 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, 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: 09421904065222
• NIH Device Record Key: 560281b7-412e-4d33-9170-36a9fd6fbf33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OviTex Reinforced Bioscaffold With Resorbable Polymer (OviTex)
• Version Model Number: F10254-0610G
• Catalog Number: F10254-0610G
• Company DUNS: 594540572
• Company Name: AROA BIOSURGERY LIMITED
• 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: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com
• Phone: 8448352246
• Email: customerservice@telabio.com

Device Dimensions

• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter
• Width: 10 Centimeter
• Length: 6 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421904065222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153633

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: 5
• Public Version Date: 2021-08-10
• Device Publish Date: 2016-09-24

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