EverPatch+ 1044002

GUDID G16010440021

Permanent Scleral Reinforcement Matrix. Two shapes (one rectangular, one shield-shaped) are provided in each unit, to be selected according to physician preference.

CORNEAT VISION LTD

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: G16010440021
• NIH Device Record Key: 4f1a6605-d5a5-41fa-b7d0-ea8467139948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EverPatch+
• Version Model Number: 1044002
• Catalog Number: 1044002
• Company DUNS: 531917352
• Company Name: CORNEAT VISION LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G16010440020 [Primary]
HIBCC	G16010440021 [Package]; Contains: G16010440020; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• QWU: Prosthesis, Eyelid Spacer/Graft, Polymer

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: 2025-01-07
• Device Publish Date: 2024-12-30

Devices Manufactured by CORNEAT VISION LTD

• G16010440021 - EverPatch+: 2025-01-07Permanent Scleral Reinforcement Matrix. Two shapes (one rectangular, one shield-shaped) are provided in each unit, to be selected according to physician preference.
• G16010440021 - EverPatch+: 2025-01-07 Permanent Scleral Reinforcement Matrix. Two shapes (one rectangular, one shield-shaped) are provided in each unit, to be selecte
• G16010362951 - CorNeat EverPatch: 2023-12-13 Permanent Tissue-Integrating Surgical Matrix