OPHTACATH® 2 mm Bilateral Kit

GUDID 13700773735102

A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

FCI S A S FCI 20 22

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 13700773735102
• NIH Device Record Key: 9612884e-735a-4f44-872f-ea7e7dfa659c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPHTACATH® 2 mm Bilateral Kit
• Version Model Number: S1.4122
• 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: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700773735102 [Primary]
GS1	13760087123828 [Previous]

FDA Product Code

• OKS: Lacrimal Stents And Intubation Sets

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: 2024-01-05
• Device Publish Date: 2023-12-28

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: 2024-07-01 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: 2024-01-05A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.
• 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