Artificial Iris Fiber Free 00095002

GUDID 04049154000029

The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This Fiber Free model is suitable for sutureless implant techniques or can be sutured. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.

HumanOptics AG

Implantable iris prosthesis

• Primary Device ID: 04049154000029
• NIH Device Record Key: a6ef86db-5748-4d3b-a1f9-da3d97ff1710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Artificial Iris Fiber Free
• Version Model Number: 95002
• Catalog Number: 00095002
• Company DUNS: 326947129
• Company Name: HumanOptics AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Device Dimensions

• Outer Diameter: 12.8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049154000029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170039

FDA Product Code

• QBT: Artificial Iris

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: 2019-10-10
• Device Publish Date: 2019-10-02

Devices Manufactured by HumanOptics AG

• 04049154000012 - Artificial Iris with Fiber: 2019-10-10 The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medica
• 04049154000029 - Artificial Iris Fiber Free: 2019-10-10The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This Fiber Free model is suitable for sutureless implant techniques or can be sutured. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
• 04049154000029 - Artificial Iris Fiber Free: 2019-10-10 The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medica