OviTex® 1S

GUDID 09421907331935

The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.

AROA BIOSURGERY LIMITED

Extra-gynaecological surgical mesh, biologic-polymer composite

• Primary Device ID: 09421907331935
• NIH Device Record Key: 9f07707d-0187-474f-9597-a4167cc543b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OviTex® 1S
• Version Model Number: F10266-0408G
• Company DUNS: 594540572
• Company Name: AROA BIOSURGERY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421907331935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250598

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: 2025-12-04
• Device Publish Date: 2025-11-26

On-Brand Devices [OviTex® 1S]

• 09421907331997: The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of
• 09421907331973: The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of
• 09421907331966: The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of
• 09421907331959: The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of
• 09421907331942: The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of
• 09421907331935: The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of