Ophthalmic trocar S9.7100.25

GUDID 53760087123987

A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture the eye to provide access to the interior of the eye for ophthalmic surgery. It is assembled and used together with a compatible cannula, filling its lumen and providing the necessary sharp point, thereby facilitating the introduction of this assembly. The trocar is withdrawn after puncturing, providing a working channel into the interior of the eye. It is typically available for use with an ophthalmic cannulation set. This is a reusable device.

FCI S A S FCI 20 22

Ophthalmic cannula transscleral trocar blade

• Primary Device ID: 53760087123987
• NIH Device Record Key: 3e37e5d5-9924-49a0-bdee-bdf7f18849c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ophthalmic trocar
• Version Model Number: RETILOCK® 25G VALVED SELF-RETAINING TROCAR
• Catalog Number: S9.7100.25
• Company DUNS: 763408366
• Company Name: FCI S A S FCI 20 22
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-932-4202
• Email: orders@fci-ophthalmics.com

Device Dimensions

• Needle Gauge: 25 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760087123982 [Primary]
GS1	53760087123987 [Unit of Use]

FDA Product Code

• NGY: Cannula, Trocar, Ophthalmic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[53760087123987]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [Ophthalmic trocar]

• 53760087123987: A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture
• 53760087123970: A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture
• 53760087123871: A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture
• 53760087123888: A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture