TearSaver® - 0.5 mm

GUDID 23700773734775

Punctum plug

FCI S A S FCI 20 22

Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug Lacrimal punctum plug

• Primary Device ID: 23700773734775
• NIH Device Record Key: dcaa9c42-040c-49a1-8af9-8d8b2fa37c0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TearSaver® - 0.5 mm
• Version Model Number: S2.3852
• Company DUNS: 763408366
• Company Name: FCI S A S FCI 20 22
• Device Count: 2
• 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: true
• Expiration Date: true
• 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	13700773734778 [Primary]
GS1	23700773734775 [Unit of Use]

FDA Product Code

• LZU: Plug, Punctum

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: 2023-11-21
• Device Publish Date: 2023-11-13

Devices Manufactured by FCI S A S FCI 20 22

• 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
• 13700773735119 - OPHTACATH® 3 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
• 13700773735126 - OPHTACATH® 3 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
• 23700773734768 - TearSaver® - 0.4 mm: 2023-11-21 Punctum plug
• 23700773734775 - TearSaver® - 0.5 mm: 2023-11-21Punctum plug
• 23700773734775 - TearSaver® - 0.5 mm: 2023-11-21 Punctum plug
• 23700773734782 - TearSaver® - 0.6 mm: 2023-11-21 Punctum plug
• 23700773734799 - TearSaver® - 0.7 mm: 2023-11-21 Punctum plugs