Orbital sphere implant introducer S6.3050u

GUDID 03760087126389

A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.

FCI S A S FCI 20 22

Orbital sphere implant introducer

• Primary Device ID: 03760087126389
• NIH Device Record Key: 655afaa9-0aef-4ecd-b3c5-342d3258a5d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbital sphere implant introducer
• Version Model Number: SPHERE INTRODUCER
• Catalog Number: S6.3050u
• Company DUNS: 763408366
• Company Name: FCI S A S FCI 20 22
• Device Count: 1
• 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: false
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760087126389 [Primary]

FDA Product Code

• HNP: Introducer, Sphere

Sterilization

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

[03760087126389]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-05
• Device Publish Date: 2020-02-26

On-Brand Devices [Orbital sphere implant introducer]

• 03760087126297: A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant i
• 03760087126389: A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant i