OPHTACATH® 3 mm Bilateral Kit

GUDID 13700773735126

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: 13700773735126
• NIH Device Record Key: 9326a22e-777a-429f-b010-fd94d24965a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPHTACATH® 3 mm Bilateral Kit
• Version Model Number: S1.4132
• 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: 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	13700773735126 [Primary]
GS1	13760087123842 [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

• 23700773707472 - MACULORHEXIS FORCEPS 27 G: 2025-04-04 MACULORHEXIS FORCEPS 27 G
• 23700773707489 - END GRASPING FORCEPS 27 G: 2025-04-04 END GRASPING FORCEPS 27 G
• 23700773707496 - TANO FORCEPS 27 G: 2025-04-04 TANO FORCEPS 27 G
• 23700773707502 - pince super grip 23G: 2025-04-04 pince super grip 23G
• 23700773707519 - pince super grip 25G: 2025-04-04 pince super grip 25G
• 23700773707526 - pince super grip 27G: 2025-04-04 pince super grip 27G
• 23700773721041 - TANO POLISHER,20G: 2025-04-04 TANO POLISHER,20G
• 23700773721058 - TANO POLISHER,23G: 2025-04-04 TANO POLISHER,23G