EZYPOR® Ø 18 mm

GUDID 13700773724397

Orbital implant

FCI S A S FCI 20 22

Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant Orbital sphere implant

• Primary Device ID: 13700773724397
• NIH Device Record Key: f8698cab-334e-41c6-b37b-e71b9bdebc4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZYPOR® Ø 18 mm
• Version Model Number: S6.6018
• 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	13700773724397 [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: 2024-07-01Orbital implant
• 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: 2024-07-01 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