Orbital sphere implant introducer

FDA UDI

Class I (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name: Orbital sphere implant introducer FDA UDI
Generic Name: Orbital sphere implant introducer FDA UDI
Device Name: 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. FDA UDI
Model / Reference: SPHERE INTRODUCER FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: S6.3050u FDA UDI
Primary DI / UDI-DI: 03760087126389 FDA UDI
FDA Product Code: HNP FDA UDI
GMDN Term: Orbital sphere implant introducer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orbital sphere implant introducer

Orbital sphere implant introducer by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orbital sphere implant introducer.

Sphere Introducer — Katena Products, Inc. · Class I
CARTER SPHERE INTRODUCER — SONTEC INSTRUMENTS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
AESCULAP — AESCULAP, INC. · Class I
SPHERE INTRODUCER — FCI S A S FCI 20 22 · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Fci S A S Fci 20 22

Sources (1)

FDA UDI 655afaa9-0aef-4ecd-b3c5-342d3258a5d9 35 fields · synced May 30, 2026