EZYPOR® Ø 16 mm

GUDID 13700773728081

Orbital implant

FCI S A S FCI 20 22

Orbital sphere implant

• Primary Device ID: 13700773728081
• NIH Device Record Key: c8d6179a-6029-4dfc-bc0a-7f38b7d951d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZYPOR® Ø 16 mm
• Version Model Number: S6.6016
• Company DUNS: 763408366
• Company Name: FCI S A S FCI 20 22
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700773728081 [Primary]

FDA Product Code

• HPZ: Implant, Eye Sphere

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: 2024-07-01
• Device Publish Date: 2024-06-21

Devices Manufactured by FCI S A S FCI 20 22

• 13700773724397 - EZYPOR® Ø 18 mm: 2024-07-01 Orbital implant
• 13700773724403 - EZYPOR® Ø 20 mm: 2024-07-01 Orbital implant
• 13700773724410 - EZYPOR® Ø 22 mm: 2024-07-01 Orbital implant
• 13700773728081 - EZYPOR® Ø 16 mm: 2024-07-01Orbital implant
• 13700773728081 - EZYPOR® Ø 16 mm: 2024-07-01 Orbital implant
• 13700773728852 - EZYPOR® Ø 12 mm: 2024-07-01 Orbital implant
• 13700773728890 - EZYPOR® Ø 14 mm: 2024-07-01 Orbital implant
• 13700773735096 - OPHTACATH® 2 mm Unilateral Kit: 2024-01-05 A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic
• 13700773735102 - OPHTACATH® 2 mm Bilateral Kit: 2024-01-05 A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic