Identity
- Trade Name
- SPHERE 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
- S6.3050 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
- Primary DI / UDI-DI
- 13760087126386 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orbital sphere implant introducer
Sphere 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
- Orbital sphere implant 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 a01c7e41-9f45-4373-86d9-5c07601508d0 33 fields · synced May 30, 2026