OviTex LPR Reinforced Bioscaffold F10244-0909L

GUDID 09421904065765

OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). 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, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite

• Primary Device ID: 09421904065765
• NIH Device Record Key: b87d5755-a063-4ca8-babe-ddcc776dd185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OviTex LPR Reinforced Bioscaffold
• Version Model Number: F10244-0909L
• Catalog Number: F10244-0909L
• 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

Device Dimensions

• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 Centimeter
• Length: 9 Centimeter
• Width: 9 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
• 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	09421904065765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153632

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: 2020-10-21
• Device Publish Date: 2018-10-26

On-Brand Devices [OviTex LPR Reinforced Bioscaffold]

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• 09421904065772: OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
• 09421904065765: OviTex™ Reinforced BioScaffold with Permanent Polymer (OviTex) is a sterile bioscaffold compos
• 09421906661569: OviTex™ Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold comp
• 09421906661552: OviTex™ Reinforced Tissue Matrix with Permanent Polymer (OviTex) is a sterile bioscaffold comp