OviTex IHR Reinforced Bioscaffold with Permanent Polymer (bean) F10244-1017I

GUDID 09421906661903

Ovitex IHR is a surgical mesh device intended to provide structural and mechanical support for soft tissue reconstruction. The device provides strength at the site of implantation where weakness exists. During the normal healing process, the device also acts as a scaffold for functional tissue remodeling. OviTex IHR 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

Extra-gynaecological surgical mesh, biologic-polymer composite

• Primary Device ID: 09421906661903
• NIH Device Record Key: 555072bc-0612-48c7-bc7d-f6cda85d9cf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OviTex IHR Reinforced Bioscaffold with Permanent Polymer (bean)
• Version Model Number: F10244-1017I
• Catalog Number: F10244-1017I
• 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: 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: 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: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Width: 17 Centimeter
• Length: 10 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dry environment.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421906661903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153632

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-29
• Device Publish Date: 2024-03-21

On-Brand Devices [OviTex IHR Reinforced Bioscaffold with Permanent Polymer (bean)]

• 09421906661927: Ovitex IHR is a surgical mesh device intended to provide structural and mechanical support for s
• 09421906661910: Ovitex IHR is a surgical mesh device intended to provide structural and mechanical support for s
• 09421906661903: Ovitex IHR is a surgical mesh device intended to provide structural and mechanical support for s